Process Validation

Process validation establishes scientific evidence that a process is capable of consistently delivering quality product. We guide you through IQ, OQ, and PQ.

Services offered:

  • Master Validation Plan
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Software validation (per IEC 62304 for medical device software)
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Process Validation Including Software

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Comprehensive guidance on EU MDR compliance requirements for medical device manufacturers.

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Application of Risk Management to Medical Devices

Integration of a risk management system into your existing quality management system.

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Post-Market Surveillance and Vigilance

Establishment and implementation of PMS to review experience gained from devices in the post-production phase.

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