Quality Systems

RegsYour Quality System is key to success in the complex regulated environment around medical devices and combination products.

We have been heavily engaged in creating, implementing and evolving Quality Systems suitable to comply with EU Medical Device Directive, ISO13485, ISO14971, 21CFR820 and streamlined approaches to address 21CFR4 from the pharmaceutical manufacturer perspective.

Lately, we have been implementing Quality Manuals to extend drug quality systems to the device constituent; conducting impact assessments for ISO 13485:2016; and anticipating the impact of MDR (EU) 2017/745.

We can help you with;

  • Identification of the applicable regulations and guidances
  • Staff and Project Team Training
  • Full design of your Quality System
  • Authorship of key procedures and supporting documents
  • Review and simplification of your current procedures
  • Preparation for Client audit, Supplier/CMO audit, Notified Body Surveillance Audit and Health Authority site inspection
  • Creation of non-Quality System guidance documents
  • … and many other aspects

We have several experiences of creating and implementing Quality Manuals, Quality System procedures, operational procedures, best practice guidances and document templates.

Talk to us to explore how we might be able to support your quality infrastructure.

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