Design Control and Risk Management Best Practices

Creating a world-class Medical Device design process

Design and risk controls are essential for medical device manufacturers to maintain the safety and effectiveness of their products throughout their development lifecycle. Add to this, the regulatory requirements of different markets to establish such controls for proof that products are being developed with both patient safety and customer requirements in mind. Applying best practices in all cases leads to a more successful business and brand recognition.

Design inputs are the foundation for product development. Design requirements should be traceable to user needs, risk control, and applicable standards.

Knowing where risks are and how to apply the proper assessment is key to understanding design controls. As the design evolves, new risks may become evident and to reduce or prevent these risks as early as possible will benefit the process and make and reduce costs.

Understanding the differences between verification and validation is important. Ensuring the product is built correctly and that it’s built for the right users are inherently different concepts which must be managed effectively.

Using an effective quality management system to link design, regulatory, risk assessment, and supplier controls will lead to a more efficient process and more reproducible results.

AlvaMed’s team of experts have helped organizations stay ahead of the curve for quality compliance.

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Design Control and Risk Management Best Practices FAQ's

Medical device design controls increase the chances of transferring the design to production, without much difference, into a device suited for its intended use.

Using appropriate design controls, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and corrected immediately in the development process. An enhanced understanding of the degree of conformance of a design to the user and patient needs

Everywhere. Risk management should be a ‘household’ word in the quality management system. It is the first line of defense when it comes to ensuring compliance with standards, regulatory requirements, user expectations, and proactively addressing issues.

Jon Saltonstall

Vice President of Regulatory and Quality Compliance

Ready to learn how AlvaMed can help establish design control and risk management best practices

Schedule time to discuss with Jon.