Medical device technical documentation – accurate, compliant, future-proof
In the medical device industry, technical documentation is much more than a regulatory requirement – it is the key to market access, quality assurance and patient safety. Whether creating new documentation or revising existing documents, I can support you with expertise, clarity and an eye for regulatory detail.
My technical documentation services include
Creation of new documentation: Development of complete, regulatory and standards-compliant documentation for your medical devices – from product descriptions to risk assessments.
Revision of existing documentation: Analysis and optimization of your documentation to ensure compliance with current regulatory requirements (e.g. MDR, IVDR, FDA) and standards.
Risk Management Documentation: Integration and maintenance of ISO 14971 compliant documents to fully map your risk management processes.
Post-market documentation: Support in the creation and evaluation of PMS reports and trend analyses; strategic action planning based on the results.
Training and consulting: Share technical documentation best practices with your team to strengthen internal competencies.
Why quality technical documentation is critical
Regulatory certainty: Accurate documentation is a prerequisite for market access for your products.
Minimize risk: Clear and complete documentation reduces the likelihood of questions, delays and compliance issues.
More efficient processes: Well-structured documentation facilitates internal processes, audits, and future updates.
Market Advantage: High-quality documentation signals professionalism and builds trust with customers and partners.
I have a deep understanding of the needs of the medical device industry and the precision and care required to get your documentation to the point. Together, we can ensure that your documentation not only meets the highest standards, but also lays the foundation for your success.
Let us take your technical documentation to a new level – clear, compliant and future-proof.