- Product design performance and manufacturability assessment
- Process capability and maturity assessment
- Regulatory and standards compliance: 21 CFR 820, ISO 13485, ISO 14971, IEC 60601
- Supply chain management and product cost evaluation
Identified issues and risks in product performance and manufacturing processes during due diligence assessment of disposable and capital system products from an acquired medical device startup.
Results: Accurate evaluation of system maturity, which drove an efficient plan for improvement.
Prioritized and managed product improvements that addressed reliability and manufacturing yield issues for medical device start-up.
Results: Improved product quality and field performance.