Quality and Regulatory
Compliance built into the design
We support teams developing devices that must meet CE, FDA or ISO standards. Our process weaves regulatory requirements into the design from the start reducing risk and saving time.
- Product requirements mapping with traceability from concept to verification
- Risk management aligned with ISO 14971 and similar frameworks
- Verification and validation plans with test case development
- Design history files (DHF), technical files, and change management
- Usability engineering and human factors analysis
- Compliance strategy and quality management systems implementation support
- Gap analysis for in-progress systems needing backfilled documentation
- Aligned support for ISO 9001, ISO 13485, IEC 61010, IEC 60601 and 21 CFR Part 11
