Newsletter V. 2019 Issue 2

Have employees new to medical devices? I offer practical training on Medical Device Design Controls either on site or at a public workshop. Contact me Agile Design Controls This is a three part recorded webinar series that illustrates a flexible and rigorous approach to managing design controls for software-intensive medical [...]

By |2019-06-05T14:20:40-07:00June 5th, 2019|News, Newsletters, V&V Testing, V2019|0 Comments

Agile Design Controls Part 3: Paperless V&V to Support Rapid Design Iterations of Medical Devices This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage testing of a large number of requirements [...]

By |2020-06-24T10:24:29-07:00May 10th, 2019|Events, Lean & Agile, News, V&V Testing, V2019, Videos|0 Comments

V&V Flowchart

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 [...]

By |2018-12-02T00:43:57-08:00December 19th, 2017|V&V Testing|1 Comment

Buyer’s Guide for Requirements Management Tools for Medical Devices

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 [...]

By |2018-05-03T17:16:39-07:00October 19th, 2017|Requirements Management, Software Tools, V&V Testing|0 Comments

Top 10 V&V Fails: Don’t Let These Common Mistakes Derail Your Verification and Validation Program

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 [...]

By |2018-01-25T09:05:57-08:00June 1st, 2017|News, V&V Testing|0 Comments

Medical Device Documentation Map

Compiling all of the DHF documentation for a new medical device can be confusing, even for experienced engineers.   That’s why I created this “map” of document interdependencies.   It’s a way to help explain graphically how the many documents fit together for a new product.   Some key points in [...]

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