Overview of Medical Device Process Validation and Regulatory Requirements

1. Overview of Medical Device Process Validation and Regulatory Requirements Before introducing a new medical device onto the market, manufacturers should have a high degree of certainty that their manufacturing processes have the proper controls in place to produce products that are safe and meet specified user, technical, and regulatory requirements. Process Validation for Medical Devices is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device. IZiel provides complete expertise in process validation for Medical Devices and assists medical device manufacturers to consistently meet required parameters through their optimized manufacturing process. IZiel works with your team to assist you to complete all the following process validation activities Process Validation Master Plan (PVMP) Process Characterization Equipment Installation and Qualification (IQ) Operational Qualification (OQ) – Performance Qualification (PQ) Test Method Development (TMD) & Validation (TMV)

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