SoftwareCPR 2016 Standards Outlook

Sherman Eagles of SoftwareCPR expects increased standards and regulatory activity related to Software and HealthIT in 2016. Here are some of the areas to watch:

  • IEC 82304-1 Health Software: General requirements for safety will be completed during the first half of 2016. It is intended that this standard be harmonized in the EU, but it is not clear when this may happen.
  • A first committee draft of the second edition of IEC 62304 will be circulated for review in the first half of 2016. The second edition will expand the scope of the standard to health software.
  • New standards for health software covering all parts of the life cycle will be proposed in 2016.
  • AAMI will move its work on HIT quality management systems and HIT risk management forward. The goal is to complete these by the end of 2016.
  • A revision of IEC 80001-1 will begin in 2016.
  • The revision to ISO 13485 will be published in the first half of 2016.
  • ISO 14971 is currently under review. It is likely that a revision (amendment or new edition) will be started in 2016.
  • A second amendment to IEC 60601-1 will be started in the second half of 2016. This amendment is scheduled to be completed in 2019. A fourth edition of 60601-1 will be started following the completion of the amendment and will be scheduled for completion in 2024. Discussions about the structure of the fourth edition will likely begin in 2017 and decisions made before work is started on the fourth edition.
  • The first deliverables from UL/AAMI 2800 on medical device interoperability should be completed in 2016.
  • AAMI TIR 57 on medical device cybersecurity risk management will be published in 2016.
  • Many documents, both standards and regulations, on security and privacy will be in process during 2016.

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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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