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PACK TPE

MEDICAL DEVICES

The medical device market is constantly evolving and constitutes a major challenge for everyone's health.

Today, the quality, safety and efficacy of products are guaranteed thanks to international standards and strict regulations.

As a French company, you play a key role thanks to your know-how in cutting-edge technologies!

In France, the medical device market is growing rapidly. European regulations have evolved in recent years to strengthen the safety of medical devices when they are placed on the market. Medical device standards, of European and international scope, provide a presumption of compliance with regulations and facilitate trade on the international scene.

Standards are therefore essential to your economic development and to the marketing of your innovative technologies.

Dedicated to small businesses, the TPE Pack is designed to facilitate the development of your activity and save time ahead of your market.

How ?

By offering you access to 3 essential services for the development of your business in a single pack at a preferential rate. With the TPE Pack, you multiply the opportunities to develop your business.

Participate in the Standardization Commission "Quality Management of Medical Devices"
  • Promote your expertise and be part of the members who count in this sector of activity
  • Position your product or service as the reference on the market
Join the influential network of AFNOR members
  • Participate in thematic meetings with the major players in your sector on current topics.
  • Benefit from free training on standardization issues and rules.
Face non-quality risks with the CObaz digital solution
  • Have the essential standards in the field of "Medical Devices" (see list of available standards).
  • Benefit from innovative services to monitor and decipher these essential standards for risk prevention.
Take advantage of the TPE pack at the preferential rate of €985 excl. VAT/year

(excluding desired additional options – subject to eligibility)

You are interested, contact us

List of standards concerned by this pack

  • NF EN ISO 10993-1 Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management process December 2020
  • NF EN ISO 10993-23 Biological evaluation of medical devices - Part 23 : tests for irritation March 2021
  • NF EN ISO 10993-18 Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process May 2020
  • NF EN ISO 10993-12 Biological evaluation of medical devices - Part 12 : sample preparation and reference materials June 2021
  • NF EN ISO 10993-9 Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products September 2021
  • NF EN ISO 10993-11 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity May 2018
  • NF EN ISO 10993-17 Biological evaluation of medical devices - Part 17 : Establishment of allowable limits for leachable substances August 2009
  • NF EN ISO 10993-7/A1 Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals - Amendment 1 : applicability of allowable limits for neonates and infants January 2022
  • XP ISO/TS 10993-19 Biological evaluation of medical devices - Part 19 : physico-chemical, morphological and topographical characterization of materials June 2022
  • NF EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes April 2016
  • NF EN ISO 13485/A11 Medical devices - Quality management systems - Requirements for regulatory purposes September 2021
  • NF EN ISO 14971 Medical devices - Application of risk management to medical devices December 2019
  • NF EN ISO 14971/A11 Medical devices - Application of risk management to medical devices December 2021
  • NF EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice August 2020
  • NF EN ISO 15223-1 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1 : general requirements September 2021
  • NF EN ISO 20417 Medical devices - Information to be provided by the manufacturer May 2021
  • FD CEN ISO/TR 24971 Medical devices - Guidance on the application of ISO 14971 September 2020
  • XP S99-223 Medical Device - Benefit risk management February 2020
  • FD CEN ISO/TR 20416 Medical devices - Post-market surveillance for manufacturers September 2020