With the FCA's Senior Manager's and Certification Regime having a greater focus on personal accountability, Senior Managers are taking more steps than ever to govern the business, manage risk and comply with the regulation. Here's how our GRC software helps you to comply with SMCR.
A Target Product Profile (TPP) provides a statement of the overall intent of the development program. But with all the other quality and compliance documentation you have to manage in medical devices, you are probably wondering - do I really need a TPP?
The new Medical Device Regulation will require many organisations to have a dramatic overhaul of how they plan, manage and record their business processes. Here, Dave Beard shares 3 tips to help you comply with the regulation.