Standards Update – 82304, 80002-2, 80001-2-9 Software

Although IEC 82304-1 Health Software: General requirements for safety has been published it is not clear when it will be harmonized in the EU. Nonetheless it appears EU notified bodies are treating it as “state-of-the-art” and are likely to expect it to be used for software products that are regulated as medical devices.

IEC TR 80002-2 Medical device software – Part 2: Validation of software for medical device quality systems is expected to be published shortly.  This Technical Report (TR) provides guidance for new requirements in ISO 13485:2016 for validating software used in quality systems.

IEC 80001-2-9 Application of risk management for IT-networks incorporating medical devices – Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities 80001-2-9 has been published.  This TR shows how a security assurance case can be used to demonstrate confidence that 80001-2-2 security capabilities have been achieved.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.