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
About Us
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.