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

Related Services

Clinical Evidence — IVDR

Under IVDR Article 56 - clinical data and performance evaluation results for device safety assessment.

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The New EU IVD Regulation (IVDR)

The In Vitro Diagnostic Regulation stipulates all requirements IVD manufacturers must comply with.

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Good Manufacturing Practice (cGMP)

Establish and implement an effective tailored cGMP system in line with requirements.

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