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)
Contact Us for Support
Process Validation Including Software

Related Services

Post-Market Surveillance and Vigilance

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

+ Learn More

MDSAP Program

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a …

+ Learn More

The New EU IVD Regulation (IVDR)

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

+ Learn More

Contact Us

We typically reply within a few hours

👋 Hi there! How can we help you today?

Fill out the form below and we'll get back to you as soon as possible.