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Medical Devices Overview

Comprehensive Regulatory Services for Medical Devices

At Medwisdom Lifescience, we provide comprehensive regulatory services for medical device registration for all classes (Class I to Class IV). Medwisdom Lifescience is your trusted regulatory partner for medical device registration across global markets. From strategic planning to post marketing surveillance, we assure our clients to support and guide them at every challenge they encounter.

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Our Expertise

Our regulatory services involves all stages of drug development, including:

  • Medical device registration
  • Grant of manufacturing license for all class of medical device
  • Test license and import license registration
  • In-vitro diagnostic device registration
  • Performance evaluation report for medical device and IVD
  • Medical device technical file compilation for regulatory submission
  • Regulatory strategy to obtain fast registration of medical device
  • Clinical evaluation report preparation in compliance with medical device registration
  • Review of labelling and promotional material
  • Gap analysis and regulatory compliance
  • 510(k) submission process

Why Choose Medwisdom Lifescience

Your trusted partner for seamless medical device regulatory success

Global Regulatory Expertise

Deep knowledge of international medical device regulations across major markets.

End to End Regulatory Support

Complete assistance from classification to post-market surveillance.

Cost Effective Regulatory Services

High-quality support delivered with optimal pricing and no compromise.

Timely Submission

Accurate preparation and proactive follow-up for faster approvals.

Effective Communication With Clients

Transparent, responsive, and client-focused collaboration at every step.

Our Achievements

100+

Projects Successfully Completed

15+

Countries Served

20+

Years of Combined Expertise

100%

Compliance Success Rate