Quality & Regulatory
Our governing quality system goes well beyond basic regulatory compliance. Our quality system was designed to provide the metrics required to drive continuous improvement in all aspects of our daily operations.
Medivative employs an integrated total system approach to quality management. 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
- Certified to ISO 13485:2003 through BSI Management Systems
- Experience working with product testing laboratories such as UL, CSA and ETL in order to facilitate product marketing clearances by assisting our customers in obtaining permission to apply UL, CSA, ETL or CE to their product.
- A quality system that is powered by a PLM (Product Lifecycle Management) database that is fully compliant with 21 CFR Part 11 that provides:
- Document and records management
- Complaint handling
- Non-conforming material disposition and trending
- Closed loop CAPA (corrective and preventive actions)
- Optional Web based access and electronic approvals
- Creation and maintenance of the Quality Plan including design and execution of any required process validations
- Supplier qualification and monitoring
- Medivative is registered with the Food and Drug Administration’s Center for Devices and Radiological Health and Center for Drug Evaluation and Research, which gives us the ability to handle, ship and package pharmaceuticals.