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Our knowledgeable team of quality and regulatory experts are experienced in implementing and reviewing  Quality Management Systems spanning the pharmaceutical, medical device, diagnostic and consumer product worlds.

We can assess your business and design needs and then implement processes compliant to:

  • ISO 13485:2016
  • ISO 9001:2015
  • Code of Federal Regulations Title 21 part 820 Quality System Regulations
  • Medical Device Single Audit Programme (MDSAP) guidance

In addition, we can offer training packages and ongoing quality system support including auditing of your processes and your supplier’s processes.

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