Quality & Regulatory
Our governing quality system goes well beyond basic regulatory compliance. Our quality system was designed to provide management and staff with the metrics required to drive continuous improvement in all aspects of our daily operations. Medivative looks at quality as the foundation for excellence. Our quality system gives us the tools to ensure that:
- Designs are accurately and rapidly transferred to production
- Products and services meet or exceed customer and regulatory requirements
- Medivative Technologies remains a strong value added supplier to all of our customers
Medivative Technologies employs an integrated total system approach to quality management. Our quality activities are not limited to inspection and test. Quality is considered at the earliest stages of design, product transfer and throughout the product life-cycle. Our commitment to quality is best highlighted by our Mission Statement: "We are committed to the pursuit of manufacturing excellence. We will produce each device as though it will be used in the care of one of our own family members."
Key Certifications & Capabilities
- FDA registered as a contract manufacturer of medical devices compliant with cGMP (current Good Manufacturing Practices)
- Certified to ISO 13485:2003 through BSI Management Systems
- Experienced working with country specific agencies for product market clearance (e.g. UL, CSA, CE)
- A quality system that is powered by a PLM (Product Lifecycle Management) database that is fully complaint with 21 CFR Part 11 that provides:
- Document and records management
- Complaint handling
- Nonconforming material disposition and trending
- Closed loop CAPA (corrective and preventive actions)
- Optional Web based access and electronic approvals
- Creation and maintenance of Design History and Technical Files
- Creation and maintenance of the Quality Plan including design and execution of any required process validations
- Supplier qualification and monitoring