The hidden treasure in your Technical File
I, as many of my peers in the medical device industry, am still, after 20 years in the business, amazed at the amount of time and effort spent on technical documentation.
The innovation and progress in the field of technical documentation don't, in any way, reflect the progress that has been made in the medical device innovations themselves.
Up to 50% of the total development effort of medical devices is spent on documentation activities.
Furthermore, it is apparent that very few people prefer spending time with documentation activities compared to innovation activities.
This is obviously a competitive dimension in our industry with massive efficiency gains to be made.
The one who masters technical documentation better than his competitor will
- shift resources to innovation and build better products
- faster market access
- hit the revenue stream earlier
There is simply gold to be picked up from the floor here.
So why are we not talking more about this? Does it have to be this way?
In the video below, presented at MedConf 2020, we elaborate on how medical device manufacturers can trim their documentation efforts while still remaining compliant.
If you want to assess your own documentation process, reach out to us on
