Risk management is a critical activity that contributes to developing safe and effective medical devices. While Excel may be an easy place to start, the interconnected nature of risk management means that data complexity grows rapidly as the product design matures and evolves, especially once design reviews and product versions are introduced. In addition to being difficult and time-consuming, using Excel can lead to costly mistakes such as missing data, broken links, and un-tracked changes.
This 10-minute Tech Talk discusses the following:
- When to make the jump from Excel to a purpose-built risk management product
- How to efficiently perform common risk activities such as preliminary hazard analysis
- How to connect the PHA outputs to design inputs for full product design traceability
- The impact that using Excel vs. a purpose-built product can have on regulatory preparedness
David Cronin, Founder and Chief Relationship Officer, Cognition Corp.
David Cronin is the Founder and CRO of Cognition Corp., providing solutions for structured data/content management and deliverables for compliance in pharmaceutical, combination, and medical device products. Previously, David was CEO for 24 years, concentrating on medical device product development and assisting companies with PMA and 510(k) submissions as well as pharmaceutical electronic reporting for Module 3 of the CTD. David has a bachelor of science degree in electrical engineering, as well as an MBA, from Northeastern University.