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Design Controls for Medical Device and IVD design

The American Food and Drug Administration (FDA), the European Community and other governments set high compliancy requirements for MD and IVD. It is the responsibility of the supplier to demonstrate that the device is and remains compliant. In addition, the design control processes and tools that are being used are subject to regulatory requirements as well (Good Manufacturing Practices).

Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase.

Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development. As a result, the end user benefits from a safe and effective product and the manufacturer benefits from a successful return on investment.

Design controls

The challenge for MD and IVD suppliers

At recent health care conferences the challenges that suppliers have in demonstrating compliancy are emphasized. The question is how to deal with this challenge? How can you irrefutably demonstrate that your product is safe and reliable and document the large amount of information in an efficient and controlled manner?

Control your design with Cockpit

Boston Scientific, Vistakon Pharmaceuticals, Medtronic, Quanta Fluid Solutions, LeoPharma are examples of companies that have successfully deployed Cockpit to demonstrate faster and cheaper regulatory compliancy of MD’s and IVD’s. Cockpit is being used to demonstrate meeting the needs of the customer (intended use) and regulatory compliance. In short: one tool to meet two important objectives.

Cockpit enables you to capture voices and requirements, risks and mitigations, tests and test results, actions and decisions. The integral design is captured through traceability. In addition you can configure Cockpit to follow your design processes by implementing its workflow capability. As a result you are in control of all your design controls, from concept design to design transfer and design changes.

Are you interested in a demonstration?

Are you interested in a Cockpit demonstration or do you want to know how Synergio can help your organization to successfully introduce a product to the market, contact us via +31 (0)85-2735185 or via info@synergio.nl.