The Principle
A principle from James Clear’s 1% Method also applies very well to regulatory affairs: Small, continuous improvements have a huge impact over time.
Minimal Change, Maximum Impact
Rather than trying to perfect everything at once, it is advisable to optimise things step by step. In practice, this means, for example, revising one chapter of the technical documentation each month or improving traceability between requirements, risks and verification – always with a clear objective in mind. For instance, consistently aligning a specific section of a product’s technical documentation with Annex II of the EU MDR.
If such minor improvements are made on a regular basis, the system will become extremely robust after a while!
From Goals to Systems
After all, the aim is not to perfect every single process, but to optimise the entire system. And this works best in small steps, iteratively, and always within the context of the bigger picture.
A functioning regulatory system depends on the right elements being linked together: design input with classification, verification with proof of compliance to standards, transfer with DoC and labelling. If you set this up in a structured way from the outset, you’ll save yourself a lot of time-consuming rework later on.
Audit Readiness is not a Sprint
Audit-ready documentation cannot be produced at the last minute. It is the result of substantiating assumptions, documenting risk decisions and ensuring that trade-offs are transparent – right from the start. Every audit comment is therefore an opportunity: a small improvement to the process, whether in the GSPR matrix, the PMS template or the literature tracking.
Conclusion
Compliance is achieved through robust processes and good documentation practices – rarely through a single project. The key question is: Which system helps you improve by one per cent every month?
Whether you wish to ensure your technical documentation is audit-ready or to structure your regulatory processes more systematically, BEO BERLIN supports medical device manufacturers in tackling precisely these challenges.
