Process Validation Including Software | MDV-Solve
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)
Related Services
The New EU Medical Device Regulation (MDR)
Comprehensive guidance on EU MDR compliance requirements for medical device manufacturers.
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Integration of a risk management system into your existing quality management system.
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Establishment and implementation of PMS to review experience gained from devices in the post-production phase.
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