Qualification et validation

Process validation :

  • FOT (first of tool)
  • SAT (Site Acceptance test)
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)

Product validation :

  • Functional product validation
  • Shelf life validation
  • Transport validation
  • Biocompatibility testing (subcontracted)

Regulatory Affairs :

  • Regulatory monitoring
  • Support for technical documentation and CE registration
  • Support for FDA registration

End-to-end support : Qualification et validation

Our products are developed and manufactured in compliance with international Health standards (ISO 13485, ISO 15378, FDA 21 CFR part 820).


A project or a question ? Contact us! Our teams are available to answer your questions and support you in the development of your projects.

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You are looking for tailor-made support ? We are here to accompany you !

 

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400 ZI LA PLAINE
01580 IZERNORE – FRANCE

mickael.rouach@clayens.com

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