20

May

2019

62304 Conformance Checklist Tool

62304, aid, standards

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This 62304 Conformance Checklist Tool is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions.

62304 can provide an excellent framework from which to design a software process for medical device, medical mobile app, and/or HealthIT software. 62304 was created specifically for this type of software – it was not just borrowed from another industry. It is a recognized FDA consensus standard and establishes much of what is expected for SDLC activities and documentation.

Keep in mind that 62304 does not cover all aspects of 21 CFR 820.30 however. It should be used in conjunction with system/device level safety standards. Also, while 62304 allows for omission of activities and deliverables in an SDLC, FDA expectations may differ based on many factors.

Download our 62304 Conformance Checklist Tool here: 62304SoftwareCPR-Checklist

SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 62304 for medical device software as well as for unregulated health software. SoftwareCPR experts, including those involved in development of IEC 62304 and related standards, are available to provide guidance on its implementation as well as training.

We hope you find this 62304 Conformance Checklist Tool to be useful. If you have any questions leave a message below:

About the author

Brian Pate

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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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TBD

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