List of Product Compliance Software and SaaS: An Overview

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Product Compliance Software

Product compliance software and SaaS tools can help you assess applicable standards and regulations, manage substances, create labels files and certificates, lab testing, and other aspects of the process. In this guide, we list some of the leading software and SaaS solutions in the product compliance space.

Price notice: The pricing examples in this guide may be outdated and are not actively monitored by Compliancegate.com


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Toxnot

Toxnot allows manufacturers, suppliers, and other parties in the supply chain to collaborate within the same platform to manage the product development and compliance process.

The software helps customers to uncover chemical hazards throughout the supply chains, find ingredient alternatives, digitize and store Safety Data Sheets (SDS), and create label files. It also sends notifications to the user when covered regulations, such as RoHS, REACH, or California Prop 65, are updated.

Pricing Examples

  • Free version
  • Professional version ($500/month)
  • Team version ($825/month)
  • Enterprise version (Flexible price based on customization)

Product Categories

  • Furniture
  • Electronics
  • Chemicals
  • Apparel
  • Consumer goods
  • Construction materials

Standards/Regulations

Key Features

  • Store data, information, and documents
  • Create sustainability reports and compliance letters
  • Product portfolio analytics
  • SDS screening and review
  • Create a “Declare Label

Location: 301 S Howes St #565, Fort Collins, Colorado 80522, United States

Stendard Solution

Stendard Solution helps companies from the industry of medical devices, food, and personal protective equipment to set up and maintain a Quality Management System (QMS). Users can create documents, manuals, and templates that comply with ISO and Singaporean standards.

Stendard Solution allows users to upload documents or synchronize them from Google Drive. Users can then make changes and review the documents in accordance with the ISO or Singaporean standards, following the guidelines offered by the platform. The software also enables users to display history edits to avoid confusion and facilitate team collaboration within the same document.

Pricing Examples

  • Free version
  • Starter version ($250 /month)
  • Professional version ($700 /month)
  • Enterprise version ($1,400+/month)

Product Categories

  • Personal protective equipment
  • Food products
  • Medical devices

Standards/Regulations

  • ISO 9001 – Quality management systems – Requirements
  • ISO 13485 – Medical Device Quality Management System
  • ISO 22000 – Food safety management
  • ISO 27001 – Information Security Management System (ISMS)
  • ISO 45001 – Occupational Health and Safety Management System
  • SS 620 – Good Distribution Practice for Medical Devices (Singapore)
  • SS 506 – Occupational Safety and Health Management System (Singapore)

Key Features

  • Create ISO/SS compliant documents
  • Create ISO-related manual and templates
  • Generate user manuals
  • E-signature functionality

Location: ARC380, 380 Jalan Besar, #13-06, Singapore 209000

Compliance Gate Platform

Disclaimer: The Compliance Gate Platform is a platform developed by us

The Compliance Gate Platform is an all-in-one compliance solution helping importers, Amazon sellers, brands, and export manufacturers understand and manage various parts of the compliance process. Here are some examples of what you can do:

  • Create product compliance requirements lists
  • Create documents/certificates
  • Create product and packaging label files
  • Book lab testing and upload test reports

Learn more

Location:14/F, China Hong Kong Tower, 8 Hennessy Rd, Wan Chai, Hong Kong S.A.R (China)

SmartCert

SmartCert by Comply Express provides an integrated suite of tools and solutions to help manufacturers, importers, and distributors from the electronic and electrical industry to achieve product compliance. The covered scope includes the EU, US, and Gulf region’s regulations.

Users can generate compliance strategy review reports, Declarations of Conformity (DoC), test plans, and identify regulatory requirements in accordance with the different regulations or standards.

Pricing Examples

  • 1-20 employees (£50/month)
  • 21-70 employees (£100/month)
  • 71-250 employees (£200/month)
  • 251-1,000 employees (£500/month)
  • 1,000+ employees (£1,000/month)

Product Categories

  • Electronic toys
  • Household appliances
  • Lamps
  • Electrical accessories
  • Digital displays
  • Fitness equipment

Standards/Regulations

Key Features

  • Generate CSR (Compliance Strategy Review)
  • Generate Declaration of Conformity
  • Document storage and management
  • Keep track of due diligence evidence
  • Keep track of harmonized standards for the products
  • Indicate the product progress level attained
  • Allow users to manage more than 1,000 products simultaneously

Location: Unit C2 Coalport House, Stafford Court, Stafford Park 1, Telford, TF3 3BD, United Kingdom

CPSIA Ready

CPSIA Ready is a product compliance management software that gives manufacturers and importers the ability to effectively collaborate with each other and comply with the requirements of the Consumer Product Safety Improvement Act (CPSIA).

CPSIA Ready provides a dashboard that shows the compliance progress of each product. It helps users to generate compliance documents such as Children’s Product Certificates, create test and production plans templates, and keep track of the latest regulatory changes. Users can arrange their priorities and tasks according to their schedules.

Standards/Regulations

Key Features

  • Create Children’s Product Certificates
  • Send compliance certificates to retailers and distributors
  • Managing material changes
  • Storing test reports and compliance documentation
  • Production track

Location: West Chester, PA 19381, United States

Safexpert

Safexpert by IBF allows users to create risk assessments, DoC, instruction manuals, and other CE-related documents for machinery. The platform provides step-by-step guidance to help users evaluate relevant standards, and prepare required documents and files according to the EU requirements.

Safexpert also allows users to quickly identify design risks using a risk graph and take actions systematically.

Pricing Examples

  • Basic plan: €780 – €3,859/year
  • Add-on services: €40 – €1,630/year

Product Categories

  • Machinery
  • Partly completed machinery
  • Low voltage electronics
  • Interchangeable equipment
  • Removable mechanical transmission devices

Standards/Regulations

  • Machinery Directive
  • Low Voltage Directive
  • ATEX Directive
  • EMC Directive
  • RoHS Directive
  • EN 60204-1 – Safety of Electrical Equipment of Machines
  • EN ISO 11553-1 – Safety of Machinery – Laser Processing Machines
  • ISO 12100 – General principles for design – Risk assessment and risk reduction

Key Features

  • Evaluate relevant standards and directives
  • Perform risk assessments
  • Compile technical documentations
  • Perform internal manufacturing control
  • Create Declaration of Conformity

Location: Heilbronner Str. 150, 70191 Stuttgart, Germany

UL Safety Management Software

UL has developed safety management software solutions that can help manufacturers and employers enhance their abilities to manage worksite safety, prevent and report incidents.

PURE® Safety

PURE® Safety is a safety management software developed by UL to prevent incidents in the workplace. It allows employers and managers to:

a. Schedule, track, and monitor facilities performances, including incidents types and frequency

b. Identify risks, log incidents, analyze causes and take corrective actions

PURE® OHS

PURE® OHS is a platform that can be accessed through web browsers and mobile devices, which allows employees to submit incidents quickly and send automated notifications to their employers or colleagues.

This software enables the quick announcing of incidents, which decreases the procedures and time to report the incidents through traditional reporting systems.

PURE® OHS also helps employers to manage the Employee Health and Safety (EHS) data and produce OSHA-compliant reports.

Standards/Regulations

Key Features

  • Instant incident report
  • Employee training
  • Generate OSHA-compliant reports

Location: Northbrook, Illinois, United States

Texbase

Texbase is cloud software that provides management solutions for manufacturers and importers of the textile industry. It allows users to manage yarns, fabric, colors, documentation, and lab testing within a single dashboard.

The platform also allows users to streamline the creation of certificates such as CPC, and to manage their Corporate Social Responsibility Programs.

Further, users can gain real-time visibility in tracking production status to reduce inventory issues, mitigate disruptions, and accelerate speed to market.

Pricing Examples

  • Small and medium-sized companies ($195/month)
  • Enterprise (customizable plan along with premium support)

Product Categories

  • Textile
  • Apparel
  • Footwear

Standards/Regulations

  • CPSIA
  • EU Conflict Minerals Regulation
  • Corporate Social Responsibility Programs

Key Features

  • Materials and testing management
  • Lab dip, print, and yarn dye management
  • Create CPC
  • Manage and monitor Corporate Social Responsibility programs

Location: 895 Technology Blvd. Ste 202, Bozeman, Montana 59718, United States

Teklynx

Teklynx is a labels and barcodes creation software that assists users in generating labels that comply with industry standards. The label creation functionality covers the industries of food and beverage, nutritional supplements, automotive, medical devices, and more.

Teklynx enables users to comply with the requirements of the US FDA 21 CFR, the EU Medical Devices Regulation, the Produce Traceability Initiative, and other regulations.

Also, Teklynx allows users to print HIBC and GS1 barcodes with support for thermal transfer printers.

Product Categories

  • Food and beverage
  • Electrical and electronics
  • Chemicals
  • Pharmaceutical
  • Medical device
  • Automotive
  • Shipping and logistics
  • Cannabis

Standards/Regulations

  • FDA 21 CFR
  • Medical Device Regulation (MDR)
  • Energy Labelling Framework Regulation
  • Drug Supply Chain Security Act (DSCSA)
  • Food Safety Modernization Act (FSMA)
  • Produce Traceability Initiative (PTI)
  • GS1 standards
  • AIAG standards

Key Features

  • Create Unique Device Identification (UDI) labels
  • Create Globally Harmonized System (GHS) labels
  • Create Medical Device Regulation (MDR) labels
  • Create nutrition facts labels
  • Create food allergen labels
  • Create beverage labels

Location: Glendale, Wisconsin, United States

Link Services

Link Services is a project management and compliance software designed by Green Arrow Labs for manufacturers and companies of the textile and clothing industry. It enables users to manage material procurement, chemical substance testing, and certificates in one single platform.

Link Services allows users to import bills of materials, manage product SKUs and create relevant documentation, such as General Certificates of Conformity (GCC).

The software also allows users to log the chemical substances present in each component or material and compares them to the chemical concentration limits set by relevant regulations.

Product Categories

  • Clothing
  • Textiles

Standards/Regulations

  • CPSIA
  • REACH
  • OEKO-TEX
  • Bluesign
  • Eco-Passport

Key Features

  • Bill of materials, materials management
  • Precision testing and sourcing
  • Product certificates management
  • Generate General Certificates of Conformity (GCC)

Location: 1204 Village Market Place, Suite #195, Morrisville, North Carolina

Product Compliance Suite

Product Compliance Suite by Assent Compliance is software that helps companies fulfill their obligations according to various product compliance regulations, such as REACH and CPSIA.

Product Compliance Suite allows the users to sync their internal PLM (Product Lifecycle Management) and ERP (Enterprise Resource Planning) systems to create bills of material and other documents in a standardized format.

Also, users can review the list of substance concentration limits and labeling requirements under applicable regulations in the EU or the US.

In addition, users can get restricted substance alerts once there are new requirements so that they can determine the proper and safe material composition of their products.

Product Categories

  • Electronics
  • Automotive parts and components
  • Medical devices
  • Industrial equipment

Standards/Regulations

  • REACH
  • Waste Framework Directive
  • Medical Device Regulation
  • RoHS Directive
  • CPSIA
  • California Proposition 65
  • Toxics in Packaging
  • Toxic Substance Control Act

Key Features

  • Material sourcing
  • Collect data throughout the supply chain
  • Generate risk reports
  • Product development scheduling

Location: 525 Coventry Road, Ottawa, Ontario, K1K2C5, Canada

RegulatoryOne

RegulatoryOne by Veeva is a software that helps companies to comply with chemical substance restriction regulations. Users can create Safety Data Sheet (SDS), and Relation Data System (RDS) using the pre-configured repository.

They can also access templates to create, revise, store and manage a wide range of documents according to the different regulations (e.g. REACH, FDA). These documents include product spec sheets, artwork, SDS, and study reports.

Product Categories

  • Chemicals
  • Cosmetic and personal care products
  • Food and beverage

Standards/Regulations

  • REACH
  • FDA 21 CFR

Key Features

  • Regulatory document creation management
  • Regulatory supplier compliance management

Location: 131 Av Charles de Gaulle 92200 Neuilly sur Seine, France

SpheraCloud

SpheraCloud is a chemical inventory management software that helps users to track chemical inventory information and maintain compliance with regulatory requirements, including REACH and the SEVESO Directive for Technological Disaster Risk Reduction.

The centralized data collection system allows the users to monitor quantities and locations of materials across different business facilities and databases. For example, users can track materials composition, properties, inventory estimates, and other information to create documents such as SDS more efficiently.

Product Categories

  • Chemical substances

Standards/Regulations

  • REACH
  • SEVESO Directive
  • Emergency Planning and Community Right-to-Know Act (EPCRA)
  • Control of Major Accident Hazards Regulations (COMAHR)
  • Globally Harmonized System (GHS)

Key Features

  • Provide SDS templates for 50+ countries
  • Managed chemical substances

Location: One Prudential Plaza, Chicago, IL 60601, United States

Gensuite Product Stewardship Software

Gensuite Product Stewardship Software facilitates collaboration among different segments, including compliance, sourcing/procurement, engineering, quality, EHS, and sales.

It allows users to maintain and monitor global product regulatory compliance and chemical requirements for their products, parts, and materials. Users can also schedule periodic tasks and obligations, assign responsibility to team members or suppliers with email notifications, and track report status inside the platform.

Additionally, users can report substances in the SCIP (Substance of Concern in Products) using the format accepted by ECHA’s system.

Product Categories

  • Chemical substances

Standards/Regulations

  • REACH
  • California Proposition 65
  • Waste Framework Directive
  • RoHS

Key Features

  • Regulations overview
  • SDS management
  • SCIP Database Reporting

Location: Not mentioned

Chemical Safety Software

Chemical Safety Software by EcoOnline allows users to upload and store Safety Data Sheets (SDSs). The software extracts the data from the SDS and indexes it to make them easily searchable.

The software also allows users to create compliant risk assessment reports associated with chemical usage according to the COSHH (Control of Substances Hazardous to Health Regulations).

It also informs provides access to the employees about chemicals to which they might have been exposed in the workplace instantly via the mobile app.

Product Categories

  • Chemical substances

Standards/Regulations

  • REACH
  • CLP Regulation
  • Control of Substances Hazardous to Health Regulations

Key Features

  • Chemical management
  • SDS management

Location: Rockland House, View Road, Rainhill, Merseyside, L35 0LF, UK

Ideagen

Ideagen is a manufacturing quality management software that helps companies to maintain operational integrity in line with applicable industry (eg. ISO) or national standards. It decreases the companies’ efforts and time in finding, translating, and interpreting compliance information related to standards such as ISO 9001 or ISO 45001.

It also helps users to manage their audit records digitally by offering a visual task tracking dashboard available to every team member.

Product Categories

  • Consumer products
  • Pharmaceutical products

Standards/Regulations

  • ISO 9001 – Quality management systems
  • ISO 45001 – Occupational health and safety management
  • ISO 13485 – Quality management systems

Key Features

  • ISO compliance
  • British Retail Consortium compliance
  • MHRA and FDA compliance

Location: Ruddington, Nottingham, United Kingdom

CE Tool

CE Tool helps users to determine applicable CE marking directives and regulations for their products. The user can then generate declarations of conformity, label files, and risk analysis based on the product type.

Currently, the use of the CE Tool is free of charge with no limit to the number of product files. The company only charges for additional services such as document check and advice after the user has created the documents using the tool.

Pricing Examples

  • 249,50€ per product for the document check-up fee

Product Categories

  • Electronic products
  • Home appliances
  • Lamps and luminaries
  • Toys
  • Medical products
  • Machinery and assemblies
  • Pressure equipment and systems

Standards/Regulations

  • CE Directives

Key Features

  • Create DoC
  • Create label files
  • Generate risk analysis report

Location: Generaal Foulkesweg 90, 6703 BZ WAGENINGEN, The Netherlands

iPoint Compliance

iPoint Compliance provides product compliance solutions starting from the beginning of the product life cycle process for industries of apparel and footwear, machinery, and automobiles.

iPoint Compliance allows users to integrate data from multiple external sources and systems such as:

  • IMDS (International Material Data System)
  • BOMCheck
  • PDM (Product Data Management)
  • PLM (Product Lifecycle Management)
  • ERP (Enterprise Resources Planning)
  • EHS (Environment, Health, Safety Strategy)

The user can then use iPoint Compliance to create and analyze SDS and assessment reports, based on the imported data.

Pricing Examples

  • Basic: 2 users/Free
  • Essential: 5 users/450€ per month
  • Professional: 10 users/900€ per month
  • Enterprise: Unlimited users/flexible price

Product Categories

  • Apparel and footwear
  • Electronics
  • Glasses
  • Semiconductor
  • Pharmaceutical

Standards/Regulations

  • REACH
  • RoHS
  • Waste Framework Directive
  • California Proposition 65
  • End of Life Vehicles Directive

Key Features

  • Check product portfolio for SVHC, REACH Annex XIV and Annex XVII
  • Impact analysis and volume calculation of SVHC
  • Create SDS

Location: Ludwig-Erhard-Str. 58 · 72760 Reutlingen, Germany

Klaes CE-Generator

Klaes CE-Generator helps users to create and analyze the required documents under the EU Construction Products Regulation.

When a user submits an inquiry to the Klaes CE-Generator, the system sends the product information to the Institut für Fenstertechnik Rosenheim (IFT). After being evaluated by the experts, which review the information manually, the software creates the required documents in the correct format. This includes label files and Declarations of Performance.

Pricing Examples

  • Consultation and calculation efforts: 140 €/hour

Product Categories

  • Construction products

Standards/Regulations

  • Construction Products Regulation

Key Features

  • Create label files
  • Create Declaration of Performance

Location: Wilhelmstraße 85 – 87, D-53474 Bad Neuenahr-Ahrweiler, Germany

EU Declaration of Conformity

EU Declaration of Conformity is a free web application developed by CE-Marking Assistant, designed to help manufacturers, importers, or distributors to create and maintain their Declaration of Conformity (DoC).

Once the user selects a product category, toys, for example, the software provides the template of the corresponding DoC, which contains instructions and explanations on how to create a compliant document.

The users can also search for relevant EN standards relevant for their product, within the repository of the CE-Marking Assistant, which can then be added to the DoC.

Pricing Examples

  • Free

Product Categories

  • Toys
  • Medical devices
  • Machinery
  • Electronics
  • Measure instruments
  • Personal protective equipment
  • Lifts

Standards/Regulations

  • Radio Equipment Directive
  • Electromagnetic Compatibility Directive
  • Low Voltage Directive
  • Machinery Directive
  • Toy Safety Directive
  • Personal Protective Equipment Directive
  • Lifts Directive
  • RoHS

Key Features

  • Create Declaration of Conformity

Location: Malta

GreenCheck Software

GreenCheck Software by APA Engineering provides compliance solutions for companies producing chemicals or chemical-containing products. The software covers REACH, SVHC, RoHS, California Proposition 65, and other chemical regulations.

GreenCheck allows users to upload data from external sources such as excel sheets, to create documents including bills of material, and supplier collection reports.

Users can also create warning files and get updates on covered regulations, or submit substances information to the SCIP database.

Product Categories

  • Toys
  • Children’s products
  • Jewelry
  • Clothing
  • Home decors

Standards/Regulations

  • REACH
  • RoHS
  • California Proposition 65
  • Waste Framework Regulation
  • Conflict Minerals Regulation

Key Features

  • Assess risk and provide compliance strategies
  • Identify new regulations or regulation changes
  • Supply chain analysis and collection of declarations
  • Identify warning label requirements
  • Chemical testing analysis

Location: Birkenstrasse 20, D-63512 Hainburg, Germany

C2P Compliance Knowledge Management Platform

The C2P Compliance Knowledge Management Platform provides a database that allows users to monitor the latest changes on regulations and standards. Users can also set up specific email alerts, to receive the updates directly in their inbox.

Through the product management dashboard, they can also assess what products fall under the scope of each covered regulation, such as the Battery Directive or the Toy Safety Directive.

C2P allows the users to manage their products by topics or regions. The users can learn more about the requirements for their products such as marking and labeling, materials, testing, and reporting.

Product Categories

  • Toys
  • Apparels and clothing
  • Footwear
  • Electronic and electrical products
  • Lighting products
  • Personal protective equipment
  • Automotives

Standards/Regulations

  • REACH
  • Battery Directive
  • Toys Safety Directive
  • RoHS
  • California Proposition 65

Key Features

  • A repository containing more than 60,000 regulations and standards
  • Tailored email alerts with advanced warning of proposed regulations and changes
  • Information and updates on the fines, recalls, reputational damage, and delayed or failed shipments

Location: Unit 9, Eastgate Avenue, Eastgate Business Park, Little Island Cork, Ireland

beCPG

beCPG is a Product Lifecycle Management (PLM) software for food, beverage, cosmetics, and personal care products management. beCPG enables users to develop their product spec sheets according to ingredients, formulations, nutritional profiles, chemical substances, using the instructions provided by the software.

The software also allows the creation of packaging labeling and other elements of the product portfolio. Currently, beCPG helps users manage regulations in over 70 countries (e.g. USA, Canada, Australia, France, Germany).

Product Categories

  • Cosmetics and personal care products
  • Food and beverage

Standards/Regulations

Key Features

  • Product specification creation
  • Bill of materials management
  • Generate technical data sheets
  • Examination on applicable regulations and standards

Location: Montrouge, Ile de France

Standards Management Software

Beuth, the national standardization body of Germany, has developed several administrator tools to help users manage their products according to the regulations and standards, including the Standard Management Software.

Through the software, users can quickly find suitable standards for their products, and track updates of the relevant standards.

It also works as a document administration platform, allowing users to customize their standard package and decide the list of standards they want to purchase from Beuth.

Pricing Examples

  • Up to 25 standards: €85/year
  • Up to 150 standards: €285/year
  • Up to 300 standards: €483/year
  • Up to 500 standards: €739/year
  • Up to 750 standards: €1025/year
  • Up to 1000 standards: €1269/year
  • For each additional 1000 standards: €905/year

Product Categories

  • Materials
  • Electronics
  • General consumer goods

Standards/Regulations

Key Features

  • Examination on regulations and standards
  • Standard procurement and management
  • Standards updates tracking

Location: Am DIN-Platz, Burggrafenstraße 6, 10787 Berlin, Germany

Substantio

Substantio is a software that helps users to manage materials and substances used in their products, by allowing them to import BOM (Bill of Materials) data from ERP (Enterprise Resources Planning) or PLM (Product Lifecycle Management) systems in CSV or XLS files.

The users can then define their own substances list, compare the level of substances present in their products against the lists or restricted substances set by regulations such as REACH, RoHS, and California Prop 65, and generate substance compliance reports for team members and customers.

Product Categories

  • Electronics
  • Toys
  • Cosmetics

Standards/Regulations

Key Features

  • Import bill of materials from ERP or PLM system
  • Identify hazardous substances in the products
  • Compliance gradings against REACH, RoHS, California Prop 65
  • Generate substance compliance reports

Location: Not mentioned

Compliance Map

Bicester Innovation Centre is a British company that develops and sells software that helps companies in the consumer-facing industries to comply with requirements regarding chemical substances regulations such as REACH o RoHS.

The destined market audience of Bicester Innovation Centre are mainly manufacturers, retailers, and distributors from the European Union and the United States.

REACH Compliance Map

REACH Compliance Map specializes in helping customers in achieving REACH compliance for their products. The company monitors any changes by ECHA concerning the SVHC candidate list, ensuring that the information in its database reflects the latest state of regulation.

It also allows the users to generate custom material declaration forms. The material declaration reports generated from REACH Compliance Map comply with the industry standards, such as:

a. IPC 1752A – Materials Declaration Data Exchange Standards

b. IEC 62474 – Material Declaration for Products of and for the Electrotechnical Industry.

SCIP Compliance

SCIP Compliance helps users to identify the need for SCIP submission, which arises when a product contains one or more SVHC above 0.1% by weight, collecting and storing data, and submit notifications to ECHA.

RoHS Compliance Software

The RoHS Compliance Software provides support for EU, China, India, UAE, and other RoHS regulations. It can be integrated with the user’s PLM or ERP system to easily import bills of materials (BOM), and assess the level of restricted substances against RoHS restrictions.

Product Categories

  • Clothing and textiles
  • Toys
  • Children’s products
  • Electronics
  • Furniture

Standards/Regulations

  • REACH
  • Waste Framework Directive
  • RoHS Directive
  • WEEE Directive

Key Features

  • Monitor SVHC list constantly and inform the users of the latest changes
  • Gather REACH, and RoHS related data through email workflows, portals, and system-to-system integrations
  • SCIP Database substances submission
  • Generate compliant material declaration reports

Location: Bicester Innovation Centre, Telford Rd, Bicester, OX26 4LD., the United Kingdom

Product Manager

Product Manager by Cosmetri is a software that is designed to streamline the development, operation, and management processes for cosmetics and personal care companies. The software helps users to manage their products from R&D formulation, regulatory compliance confirmation, testing, and the final production process.

The Product Manager clarifies the checklists and numerates the suggested steps the users should follow, in order to achieve compliance. It also filters raw materials and substances property tags (e.g. organic, halal, or vegan) to assist the users during the research and development stage.

Pricing Examples

  • Starter: €41/month
  • Business €108/month
  • Enterprise: €242/month

Product Categories

  • Cosmetics

Standards/Regulations

  • EU Cosmetics Regulation

Key Features

  • Assist in R&D formulation development
  • Testing management
  • Material requirements planning
  • Packaging design and development
  • Cost calculation

Location: Bülowstraße 66 10783 Berlin Germany

Quality Management Software

Greenlight Guru’s cloud-based Quality Management Software is designed to simplify the CE Marking compliance process for medical devices.

It helps the users to identify applicable harmonized standards and create technical files and Declarations of Conformity. In order to do so, it provides templates that users can fill in with device descriptions, wiring and circuit diagrams, a list of standards applied, instruction manuals, or test reports.

Product Categories

  • Medical devices

Standards/Regulations

  • Medical Device Regulation

Key Features

  • Determine the classification of the device
  • Assist in preparing a CE marking technical file or design dossier
  • Assist in preparing a Declaration of Conformity

Location: 601 S Meridian St Suite 500, Indianapolis, IN 46225, the United States

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    Disclaimer: The Site cannot and does not contain legal advice. The legal information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, before taking any actions based upon such information, we encourage you to consult with the appropriate professionals. We do not provide any kind of legal advice. THE USE OR RELIANCE OF ANY INFORMATION CONTAINED ON THE SITE IS SOLELY AT YOUR OWN RISK.

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    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
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