Validation
Global Interconnect is a contract manufacturing partner for the medical device industry, experienced in validating medical devices. Once verification parts are approved, we move to validation, including process documentation, IQ and OQ validations, initial production (PQ), and data collection. We ensure continuous data gathering and transparent communication with our customers throughout the process.
During the validation stage, medical device OEMs expect key deliverables from their contract manufacturing partner to ensure the product meets regulatory and quality standards before production, including:
- Design Validation
- Process Validation
- Equipment Qualification
- Supplier and Material Qualification
- Risk Management Documentation
- Test Method Validation
- First Article Inspection (FAI)
- Regulatory Compliance Documentation
- Quality Control and Inspection Plans
- Manufacturing Work Instructions and SOPs
- Training and Competency Documentation
- Validation Master Plan (VMP)
