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How Kemsys can help you

Medical Industry

Kemsys Medical Industry group is a one stop solution for medical device manufacturers for their product realization and manufacturing requirements. We are one of very few companies capable of offering high quality medical device development services. We work closely with regulatory bodies to develop your product as per FDA 510k, FDA PMA and MDD requirements.

Our mature processes in multi disciplinary technologies with greater understanding of medical device regulatory requirements and production methodologies help us deliver cost effective high quality medical systems.

The following are the product design and regulatory compliance solutions that Kemsys offers to medical device manufacturers:

  • Medical equipment concept, Design, Prototype and Validation
  • Medical safety certifications - UL, TUV
  • Medical device construction change
  • Compliance engineering consulting
  • Evaluation/testing for FDA 510(k) submission
  • CE marking assistance
  • Quality consulting
  • Risk Management (ISO 14971:2007) consulting
  • Pilot Manufacturing
  • Product Manufacturing
  • After Sales support

Why Kemsys

QMS:

Our Quality Management System meets the requirements of ISO 13485:2003 & 21 CFR 820 (QSR) Standards.

Risk Management:

Kemsys carries out risk management activities as per ISO 14971, IEC 62304 standards.

Product Testing:

Product testing as per IEC, FCC guidelines.

Technical File:

Product documentation process as per FDA & CE requirements.

Product Manufacturing & Services:

Kemsys offers complete product manufacturing after sales support service.