+49 (0) 176 57694801 info@medsyscon.com
MedSysCon Medizintechnik GmbH MedSysCon Medizintechnik GmbH
  • Home
  • About
  • Blog
  • Services
    • Quality Management
    • Risk Management
    • Regulatory Consulting
    • Usability
    • Clinical Evaluation
    • Software Development
    • Project Management
  • Contact
  • Partners
  • References
  • English

FDA recognizes ISO 14971:2019 as consensus standard

MedSysCon Medizintechnik GmbH, ISO 14971:2019, Risk Management
23 Feb

FDA recognizes ISO 14971:2019 as consensus standard

Risk Management

Third Edition gets recognized

On Jan 14, 2020 the US FDA has granted Recognized Consensus Standard status to the third edition of the ISO 14971 risk management standard for medical devices and IVD products ( see: FDA Recognized Consensus Standards ).

Transition Period

The transition period of the previous standard edition, ISO 1497:2007, will last through late 2022. Therefore, any declarations of conformity to ISO 14971:2007 included in medical device and IVD premarket submissions will be accepted by the FDA until December 25, 2022.

Afterwards a medical device submission requires a declaration of conformity to the latest edition ISO 14971:2019.

Please get in touch with us for any further support:

www.medsyscon.com/en

info@medsyscon.com

+49-176-57694801

Blog Overview

Services

  • Quality Management/
  • Risik Management
  • Regulatory Consulting
  • Usability
  • Clinical Evaluation
  • Software Development
  • Project Management

Links

  • Imprint
  • Privacy policy
  • Conditions

Follow us

  • linkedin
  • xing
  • twitter
  • facebook
  • instagram
  • youtube
  • pinterest

Copyright © 2018-2021 MedSysCon Medizintechnik GmbH. Alle Rechte vorbehalten. All rights reserved.