Accelerating MedTech approvals: Implementing end-to-end development quality
Today, medical device developers face a double challenge: products must reach the market faster, while MDR/IVDR, FDA, cybersecurity requirements, and EUDAMED continue to tighten documentation standards. The difference between “ready” and “regulatorily compliant” rarely lies in the final test loop, but rather in the quality of the requirements, the consistency of the documentation, and the reproducibility of the tests.
The white paper “Development Quality in MedTech” shows how to build development quality in such a way that the regulatory evidence trail is established from the very beginning—rather than having to be painstakingly reconstructed at the end.
What to expect in the white paper
- Clear guidelines on how early development quality accelerates MDR/IVDR and FDA approvals.
- Practical principles for requirements, system design, integration testing, test bench technology (including FAT/SAT), and documentation.
- A concise overview of the most important standards: MDR/IVDR, FDA, ISO 13485, EN ISO 14971, IEC 62304, IEC 60601-1/-1-2/-1-3, IEC TR 60601-4-5, and IEC 81001-5-1.
- Checklists for “Ready-for-Design-Freeze” and “Regulatory-Ready,” ready for immediate use in day-to-day project work.
- Real-world application examples: X-ray test bench with FAT/SAT, endurance test bench for pumps, and wearable device validation including cybersecurity.
Download it here for free!