Process development and validation of the process is governed by Good Manufacturing Practices (GMP) as defined in the U.S. Code of Federal Regulations - Title 21 (21 CFR Part 820). Medical devices developed with Phase 2 Medical will be developed using a Master Validation Plan (MVP) that governs the process, testing, and quality requirements to validate that the product is made corrrectly.
Phase 2 utilizes a validation method that is widely used in the medical device industry and governed by our ISO 13485 registration. As part of the product development cycle, Phase 2 works with our clients to develop a robust and repeatable process that can be used in manufacturing. Additionally, we utilize LEAN production methods to work with our clients to acheive single-peice flow for their production.
Installation Qualification - Operational Qualification - Process Qualification
Once we have developed the process, we complete IQ/OQ/PQ to validate that we are manufacturing product as intended. This validation will extend to both the manufacturing method for components (in the case of injection molded parts) and the assembly process within our ISO Class 8 cleanrooms. We utilize our Quality Management System (QMS) and Master Validation Plan (MVP) to ensure that we build product to specification in a robust and repeatable method.
FMEA & pFMEA
Phase 2 uses these proven engineering methods to predict and identify the potential failure modes and effects for manufactured medical devices. These methods are part of the validation plan and it is important that we work closely with our client to understand the intended use of the product in the field so we can prevent product defects before they happen.