[updated NOV 2023] “One approach to satisfy two sets of rules” for medical device software As stated in the last blog post, there are two sets of rules for medical device software—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the international IEC 62304 standard, which is easier […]
FDA Software Guidances and the IEC 62304 Software Standard Read More »
Aaron Joseph and Roger Tang, PhD, Principal at HR Tang Consulting A successful product development process for innovative products is naturally comprised of two mindsets. Early in the product development process, where the uncertainty is the highest, the team’s focus is on rapid learning to close knowledge gaps. These knowledge gaps are those that are
The Two Minds for Successful Product Development Read More »
Beginner’s Guide to Medical Device Software “Medical Device Software for Newbies” or “Why is this stuff so confusing?” This article is designed for people who are new to medical device software—either experienced with software but not medical device regulations or experienced with medical device hardware only. Why is software special? References on medical cybersecurity for
Newsletter V. 2018 Issue 1 Read More »
Beginner’s Guide to Medical Device Software “Medical Device Software for Newbies” or “Why is this stuff so confusing?” Many times I’m asked to explain to engineers how to manage compliance for medical device software development. From newcomers to experienced professionals, it remains a source of confusion and frustration. And a lot of the confusion comes
Intro to Medical Device Software Read More »
Aaron Joseph helped Luma Therapeutics develop our quality system procedures and DHF documentation for the Luma Light System in 2017. This was in preparation for an FDA 510k filing. He came in on time and under budget for his services and was a valuable addition to the team. He has a pleasant, relaxed demeanor, always
On-time and under budget Read More »
V&V Flowchart by Aaron Joseph Design verification and validation (V&V) is a key part of medical device development but can be confusing to engineers, especially those who are new to the medical device industry. This “V&V Flowchart” is intended to help clear up that confusion. V&V testing is typically illustrated in the quality system with this
Maintaining traceability and DHF documentation with tedious manual methods burdens your engineers and risks compliance problems. Many medical device companies are now implementing requirements management (RM) software tools to automate traceability and DHF documentation. These tools can keep all of your risk management, requirements, and V&V documentation up to date while supporting rapid design iterations
Buyer’s Guide for Requirements Management Tools for Medical Devices Read More »
The successful market introduction of a medical device requires design verification and validation testing (V&V) (per 21 CFR 820.30 and ISO 13485 7.3). Even for experienced teams, V&V can be very challenging, requiring tight coordination of multiple activities and the correct execution of many preceding activities. I have worked on V&V testing for a wide
This short video provides an overview of Agile methods and an in-depth discussion of the practical considerations for satisfying regulatory requirements. A panel of three medical device professionals, with decades of experience across dozens of medical device companies, provide an in-depth overview of the practical realities of adopting Agile methods for medical device software development.
Why Haven’t More Medical Device Companies Embraced Agile? Read More »
Here are some good online resources: http://www.leanprimer.com/downloads/lean_primer.pdf – good overview of lean principles written by two software management consultants (Craig Larman and Bas Vodde) who include aspects of software agile methods as well. http://theleanthinker.com/ – a blog by Mike Rother with lots of good observations and real-life issues involved in changing an organization to lean http://www.lean.org/ – Lean Enterprise
Suggested Resources for Lean and Agile Product Development Read More »
