Overview
Our Medical Devices Experts provides services for registration of your products globally, supporting with New Product Approval, Post Approval, and in-house representative for various countries, EU Medical Device Regulation and Part 11 and Computerized System Validation for your products.
Expertise
- Evaluating the electrical safety and effectiveness of medical devices and equipment in compliance with IEC 60601, ISO 11607, ISO 11607-1, ISO 11607-2
- EMC regulation Directive 2014/30/EU and Mechanical and Performance testing.
- Sterile Medical Devices Microbiological Testing a per ISO 13485 Regulators in Europe, require medical device manufacturers to eliminate or reduce contamination risks in their production processes that could cause infections in patients or users.
- Medical Device Biocompatibility Testing as per ISO 10993 Series
- Clinical Evaluation Reports (CER) for Medical Devices and MEDDEV 2.7.1 rev 4
- Vigilance and Incident Reporting of Medical Device
- Medical Device Companies ISO 14971 Risk Management Consulting a per ISO 14971
Advantages
- Cost-effective
- End-to-end Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of personal care and cosmetic products like Skincare, Oralcare, Hair care, Baby care and beauty products.
- Expert support for region-specific Regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach to ensure quick product launch or market access
