Requirements Management

How to set up a quality system for a medical startup

(or “achieving compliance without bringing everything to a crawl”) Creating a quality system is fundamental for a medical startup because 1) it’s the law, and 2) it ensures a safe, reliable product. While a good quality system encompasses best practices at a company and makes the most of each employee’s [...]

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

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 [...]