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Medical device manufacturing is one of the most heavily regulated industries in the world. Even the most minor mistakes in medical product design, validation, or submittal can be costly at best, delaying time to market and at worst failing to get a product to the market at all.
The international regulatory environment changes quickly; to navigate this complex landscape requires skill, knowledge, and experience. Up-to-date awareness of FDA, ISO and industry trends is vital for success. MEDIcept is a medical quality assurance, regulatory and medical device consulting, and contract testing firm with over a 100 years of combined experience with some of the world’s largest and smallest medical device manufacturers and plasma fractionators.
We provide a comprehensive range of services including:
- Regulatory Strategy & Compliance
- Validation Testing
- Due Diligence
- Emergency Assistance
- Source Plasma and Blood Facility Compliance
- Quality Assurance
- Start-up Assistance
- Outsourced Quality Assurance (OSQA)