Overview
As per WHO “Medical Devices” are defined as “any article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.”
Expertise
- Medical Device Classification
- Good Manufacturing Practice (GMP) Compliance & Remediation Services
- Compilation of documents and Submission
- Regulatory assistance in Pre-Market Approval of Application (PMA), Premarket Notification 510 (k), De novo Submission, Submitting 513(g) Submission
- Establishment Registration for manufacturers, repackages, distributors and re-labelers
- Listing of Medical Device with FDA
- Labeling of medical devices in accordance with regulatory requirements.
