Regulatory Affairs & Quality Management in medical technology
How mid-sized companies really work: a practical benchmark on time allocation, system landscapes, interfaces and the use of generative AI.
- Format
- Length
- 41 pages
- Research
- 28 interviews
- Language
- German
It is well documented that the regulatory burden on mid-sized medical technology companies is growing. Where exactly it lands in day-to-day work is not. For this benchmark, we spoke with manufacturers, notified bodies, CROs, consultancies and industry associations from Germany, Austria and Switzerland.
The result: the bottleneck is not professional judgement. It comes before that, in the documentation. Time is lost searching, cross-checking, updating and reworking, and that is also where it can be won back.
What to expect
- Where the time in RA and QM teams really goes
- Why digital is still a long way from findable
- The biggest disconnect: between manufacturer and notified body
- Where generative AI already lightens the load today, and where it does not
- Four maturity levels and concrete areas for action for your team
Who it’s for
Regulatory affairs, quality management and management teams at medical technology manufacturers, CROs and consultancies.
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