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.

Our Expertise

• 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

• Global Regulatory Expertise
• End to End Regulatory Support
• Cost Effective Regulatory Services
• Timely Submission

Effective Communication With Clients