Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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LEARN MOREFor any MedTech company, understanding and supporting a robust and finely tuned internal Quality Management System (QMS) can be a competitive advantage rather than just a cost of doing business. And it’s imperative. Medical device manufacturers around the globe are required to maintain a Quality Management System to ensure safety and efficacy. Subsequently, they are also required to comply with regulations regarding Design Control to ensure that specific requirements for their devices are met.
Whether an organization is adhering to the FDA and its Quality Systems Regulation (QSR), the European Union and its Medical Device Regulation (EU MDR), or other regulatory authorities and standards for Design Control, it is important to manage the ongoing Quality Management process and provide documented evidence that a well-defined, controlled process is in place and has been properly executed. Under EU MDR, not only must technical documentation be current and demonstrate conformance with requirements, but it must also reflect the development stages applied to the design of the device.
Whether the Design Control process is being executed for the development of a new product (pre-launch) or to update an existing product (post-launch), this record of development is important for compliance, but even more importantly, it is essential for managing the product’s lifecycle.
How does an effective Design Control process support downstream quality activities in a product’s lifecycle?
An effective process produces a Design History File, providing documentation for each phase in the design process, including:
Having all Design evidence and documentation located in a single source of truth, Design Control, will simplify the audit process, shorten audit cycle times, and reduce audit findings.
Design Inputs captured during product development, prove necessary when investigating a complaint by enabling the manufacturer to answer investigation questions such as:
Design Inputs may be necessary to understand the nature of a Nonconformance, such as to identify possible hazards, including use error, that was anticipated in the Risk Analysis or Human Factors design evidence.
Design Control Outputs, including key information such as Product and Packaging Specifications, are required to establish supplier contracts.
An effective Design Control process integrates and creates a feedback loop with these and other QMS activities, allowing, for example, the ability to cross-reference post-market data with design documentation.
A medical device manufacturing organization will gain tangible efficiencies when they manage these Quality processes as an integrated eco system.
When Change Management, Document Management (including Medical Device File), Design Control, and Risk Management are fully integrated and cross-referenced, a manufacturing organization will experience a reduction in errors, reduced audit findings, shortened cycle times and improved end-to-end process visibility. Finally, with a complete set of technical documentation (Medical Device File, DHF), product registration should go much more smoothly by being in a position to provide the authorities with what they need, when they it.
Discover the key role Quality plays in monitoring and managing an organization’s design control process.
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