Medical Device and Pharmaceutical Product Development and Compliance

In the highly regulated world of medical device manufacturing, the relentless requirement to minimize and mitigate risk places a huge onus on design, development, and manufacturing teams. That’s why companies, large and small, are looking for software solutions to help ensure consistency and objectivity in the creation, auditing, and monitoring of critical risk management processes.

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel...

SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.