Do you equate MDR 2017 with Monstrous Documentation Regulation?
European medium-sized medical device manufacturers in particular are rightly expecting compliance with MDR to significantly impact their documentation efforts and drive up costs. Alongside these regulatory changes comes the fear of being outpaced by the competition because of disorganized, sluggish workflows.
One of the main issues is that many device manufacturers are still dependent on manual and paper-based processes. This approach might have worked well in the past, but the more product complexity increases and development cycles shorten, the more difficult it is to keep pace.
The good news is that medical device manufacturers don’t need to make any tradeoffs in efficiency to comply with the new regulation.
Consider the story of Stryker Endoscopy - one of the many medical device manufacturers we work with in the context of very similar regulatory requirements. Imagine if your Technical Information Files (the European equivalent to the FDA DHF) were integrated with all your product documentation and accessible within a single data source? Watch this 1-minute video to hear for yourself how Stryker managed to achieve this vision and improve documentation and traceability.
Don’t hesitate to reach out to a PTC Medical Device expert to brainstorm how PTC can make the transition to the new MDR as simple as possible.