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 in hardware and software.
Your team can take advantage of these benefits if you know what features to look for in a RM tool and how to manage its implementation. I have compiled a detailed Buyer’s Guide to help you choose the right RM tool for your needs and ensure a successful implementation. Part 1 of the Buyer’s Guide explains the basic functions of a RM tool and how much to expect to pay for one.