Quality Management Consulting For Medical Devices

The most important element of getting your medical device released /cleared is the implementation of quality management system in compliance with global requirement.

A sound quality management system in compliance with the international requirements will provide your company a structured method for your processes and aid in obtaining your certification.

Our quality service team provides support to implement or enhance your quality management system for applicable regulatory requirements based on your global strategy and market approval requirement.

Lexium Team can support your Quality Management System (QMS) with :
  • Gap Analysis
  • QMS Development, Support, Review and or maintenance according to ISO 13485 (EU), 21 CFR part 820 (US)
  • ICMED 13485 (INDIA) or other global markets
  • Conduct / Prepare Audit, Internal Audit, Vendor Audit, Pre Assessment Audit etc.
  • Prepare / Support / Attend Certification Assessment Audit by Authorities
  • Equipment Qualification / Validation
  • Process Validation
  • QMS / Audit Training
  • Coordination with Notified Body
  • Being your Internal Quality Person / Support

Please call our QMS experts for your requirements