Quality Management and Design Control Requirements for MedTech

Todd Neal, Product Manager, IQVIA Quality Compliance

For 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 for medical devices 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.

Maintain the Books

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?

During an Audit: Internal or External

An effective process produces a Design History File, providing documentation for each phase in the design process, including:

  • Design & Development Plans and Procedures
  • Design Inputs such as Product and Regulatory Requirements and Risk Analysis
  • Design Outputs such as Design Specifications
  • Verification and Validation test plans and report
  • Final design transferred to production, with plans for its manufacture

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.

Support Complaint Investigation Design

Inputs captured during product development, prove necessary when investigating a complaint by enabling the manufacturer to answer investigation questions such as:

  • Is the complaint consistent with product’s Intended Use?
  • Is it consistent with expected Performance Requirements?
  • Is the complaint consistent with any adverse events identified in our Risk Analysis?

Nonconformance and CAPA Management Support

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.

  • Did Design Verification test for the Nonconformance scenario?

Supplier Quality Management

Design Control Outputs, including key information such as Product and Packaging Specifications, are required to establish supplier contracts.

  • Verification test plans and reports ensure quality requirements are maintained.

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.

Experience the Efficiencies

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.

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