Our comprehensive approach and frameworks have helped MedTech OEMs contain their quality costs and stay compliant with changing global regulatory environments. Our QARA SME’s and engineers are trained and experienced on various industry regulations and standards - ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, IEC 60601, 62366, 21 CFR part 11, MDD/MDR, ISO/IEC 27032, HIPPA etc.
Service offerings
Compliance
- Supplier quality management
- Remediation support
- EU MDR/ IVDR/ GDPR
- REACH/RoHS
Regulatory
- Gap analysis for standards/regulations
- Documentation support
Quality
- Risk management
- Post market surveillance support
- Non-product software & process validation (IQ/OQ/PQ)
