Category: Medical Devices

List of Medical Devices Lab Testing Companies: Our Top 11 Picks

Posted on by Chuiyan Mo — 2 Comments

Medical Devices Testing Lab

Product compliance is essential when importing or manufacturing medical devices, including face masks, medical gloves, and other products. Verifying medical device compliance requires the involvement a of qualified third-party testing company.

In this guide, we’ve listed 11 lab testing companies in the United States, Europe, and Asia, offering a wide range of testing and certification services for medical supplies. Continue reading List of Medical Devices Lab Testing Companies: Our Top 11 Picks

FDA Regulations For Medical Devices: An Overview

Posted on by Vincent Cheng — 1 Comment

FDA Medical Devices Regulations

Are you planning to import, export, or manufacture medical devices in the United States? In this guide, we introduce you to lab testing requirements, classification, device registration, labeling, GMP and premarket submissions.

Mentioned Products

  • Medical thermometers
  • Medical masks and respirators
  • Medical gloves
  • Medical gowns

Continue reading FDA Regulations For Medical Devices: An Overview

Face Mask Regulations and Standards in the United States: An Overview

Posted on by Vincent Cheng — 2 Comments

Face Mask Regulations United States

Planning to import N95, N99 or other face masks into the United States? In this guide, we cover the basics of face mask and respirator standards, FDA requirements, labeling requirements, lab testing, and more.

Mentioned Products

  • 3-ply, 4-ply and 5-ply surgical masks
  • N95, N99, N100 masks or respirators
  • FFP1, FFP2, FFP3 masks and respirators
  • KN95 masks or respirators

Continue reading Face Mask Regulations and Standards in the United States: An Overview

Face Mask Regulations and Standards in the EU: An Overview

Posted on by Vincent Cheng — 15 Comments

Face Mask Regulations in the EU
Planning to import medical or protective face masks to the European Union? In this guide, we cover product regulations, EN standards, labeling, certification, and lab testing requirements when importing or manufacturing various types of face masks for the EU.

Mentioned Products

  • 3-ply surgical face masks
  • 4-ply- surgical face masks
  • 5-ply surgical face masks
  • FFP1 mask or respirators
  • FFP2 masks or respirators
  • N95 masks or respirators
  • FFP3 masks or respirators
  • N99 masks or respirators

Continue reading Face Mask Regulations and Standards in the EU: An Overview

EU Medical Devices Directive Guide: By Anssi Ilmari Tynjälä

Posted on by Fredrik Gronkvist — 1 Comment

Medical Devices Directive

Face masks, medical gloves, and other medical devices are regulated by the Medical Devices Directive in the European Union. The scope of the Medical Devices Directive covers safety standards, labeling, quality management systems, product registration, and documentation. Further, some medical devices are more strictly regulated than others.

In this guide, written by Anssi Ilmari Tynjälä from Innovapro, you will learn what it takes for importers and manufacturers to ensure compliance with the Medical Devices Directive. Continue reading EU Medical Devices Directive Guide: By Anssi Ilmari Tynjälä