Overview
Our Medical Devices Experts provide services for global product registration, supporting New Product Approval, Post Approval, and in-house representation for various countries. We also assist with EU Medical Device Regulation, Part 11, and Computerized System Validation.
Expertise
- Electrical safety and effectiveness testing in compliance with IEC 60601, ISO 11607 series
- EMC regulation compliance (Directive 2014/30/EU) and mechanical/performance testing
- Sterile medical device microbiological testing per ISO 13485 to minimize contamination risks
- Biocompatibility testing as per ISO 10993 series
- Clinical Evaluation Reports (CER) per MEDDEV 2.7.1 rev 4
- Vigilance and incident reporting
- ISO 14971 Risk Management consulting
Advantages
- Cost-effective
- End-to-end regulatory consultation
- Experts with hands-on experience across personal care, cosmetics, and medical devices
- Region-specific regulatory support
- Interactions with Health Authorities (HAs)
- Structured approach for faster product launch or market access
