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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.

AlvaMed’s dedication to quality and compliance is truly commendable. Their prompt and transparent actions in addressing the DHF audit findings showcase their commitment to excellence. What stands out to me is their meticulous gap assessment and proactive approach to risk management, which clearly illustrates their commitment to continuous improvement. I’m confident in their ability to maintain these high standards and look forward to continued collaboration.

Angel Iglesias

Anika

RenovoRx had the opportunity of collaborating closely with AlvaMed on a critical project involving lot release and risk management updates. AlvaMed’s dedicated team has consistently gone above and beyond to ensure the success of this project. Thanks to AlvaMed’s support, we have not only achieved the necessary updates but have also enhanced the efficiency and quality of our manufacturing processes. Their expertise and collaborative approach make them a valued partner, and we highly recommend their services to anyone seeking support in medical device compliance.

Bob Strasser

RenovoRx

We were looking for a consulting company to help us with all areas of quality affairs: implementing our first QMS, requirements development, risk management and design verification planning. AlvaMed has a pulse on the size of our company and capabilities and a good understanding of how to support our timelines and resources. AlvaMed right-sized our QMS by considering our internal and outsourced activities. AlvaMed’s experience was invaluable in anticipating needs before they became critical and stepped in as needed with varying levels of support. I would highly recommend AlvaMed to any medical device company.

Michael Pereira

MVS Surgical

Mark’s company AlvaMed is staffed with resources that can bring considerable experience to bear on problems that plague companies developing products in the medical device space. On one large program, we hired AlvaMed to analyze a collection of system specification deliverables to identify any missing, incomplete, or conflicting requirements. The AlvaMed team analyzed hundreds of pages of specifications and returned a detailed report within two weeks. Their quick turnaround and insightful comments allowed the development team to correct several requirement deficiencies and helped keep a critical milestone design review on track. Based on their outstanding combination of experience, responsiveness, and performance I would strongly recommend AlvaMed to medical device manufacturers who need help with product development or risk management issues.

Tim Wech

Program Manager, Boston Scientific

Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.

President

MedTech Client

…you were a one-stop shop – I was able to focus on my business as opposed to managing consultants….

VP Quality Assurance

Teleflex

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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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. 

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