Regulatory Compliance, Gap Analysis & Remediation

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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, Haircare, Baby care, and beauty products.
  • Expert support for region-specific Regulatory complexities
  • Interactions with Health Authorities (HAs)
  • A structured approach to ensure quick product launch or market access