Medical Device Registration In India

We are the group of experienced and energetic health care professionals, regulatory compliance consultants and doctors. We serve many segment of Medical device industry with emphasis on Orthopedic Implant, Internal Prosthesis Replacements, Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion Sets, Cardiac Stents, Drug Eluting Stents, Catheters, Intra ocular Lances, I.V. Cannulae, Heart Valves and Bone Grafts/Bone Cements.
We serves only for medical device industry and offer a wide range of services that includes
  1. Medical Device Factory Layout Planning and factory setup service.
  2. Manufacturing Licensing consultancy service (In form 28).
  3. Import Licensing consultancy service (In form 10).
  4. Consultancy for medical device registration and approval in India (In form 41).
  5. Quality Systems Implementation service.
  6. ISO 13485 and CE Certification consultancy service.
  7. Audit preparation, Document preparation and Quality management system Training.
  8. Clinical Evaluation and Risk Management.
  9. US FDA 510(k) Consulting for Medical Devices.
  10. Consultancy for Medical Device Registration in India.
  11. Indian authorized agent for medical device companies.
Based in New Delhi, we assist domestic firms throughout the INDIA, as well as international clients mainly in Asia (China), USA and Europe.
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