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Integrating Regulatory Compliance and Decisions with Design Controls and Risk Management

The Situation

A U.S. manufacturer is dissatisfied with the length of time it takes to develop Class II and III medical devices.

The Solution

RQMIS first identified both primary and secondary root causes of the process ineffectiveness and inefficiency, then conducted a gap analysis of the design control and risk management process. This data led to a redesign of the design control and risk management processes.

Bottom line: the manufacturer has achieved shorter development times overall.

RQMIS Saves Time and $$: Product Development

Integrating and aligning the design control and risk management process to assure that it is producing the necessary product specifications, standards compliance and testing, not only assures that you have developed a safe and effective medical product, but also that you satisfy regulatory authorities around the world, is a challenge. To do this efficiently is an even greater challenge.

A company that does not integrate these processes to satisfy not only their internal requirements, but that of the regulatory authorities, can have significant delays to market, increased costs to the development phase, or ultimately risk clearance/approval of their product. However, the companies that can design their quality system processes to integrate these processes (and the departments that support them) will develop a medical product that more effectively satisfies the customer (both patient and regulatory authority), and will develop that product at a lower cost. No where is this seen more prominently than in the changes to medical device designs after they are released to market.

Medical device companies often engage in continuous updates to designs based upon field use and recommendations from customers. Some of these changes are truly minor, others more significant. Those more significant changes will result in additional regulatory submissions -- 510(k), PMA Supplements, and so on. Equally important is that these design changes must have design control requirements applied to them. Many of these design changes can be addressed by Note To Files (NTFs) to document the rational as to why the company did not file a new regulatory submission. This can reduce the time to implement these changes by months. However, these NTFs must be supported with complete design control documentation.

The situation: a US manufacturer was frustrated by the long product development cycles of their class II and III medical devices and their less than robust response to design changes after market release. The regulatory requirements were often given as the excuse: "We didn't know FDA would require this test" or the regulatory department told us about this requirement after the project was 80% complete".


  • Identified both primary and secondary root causes to the process ineffectiveness and inefficiency
  • Provided a detailed gap analysis of the design control and risk management process
  • Redesigned the design control and risk management processes, including the effects of these changes to the change control process
  • Assured the updated processes produced the necessary documentation and testing for regulatory submissions or NTFs at the appropriate time

As a result of these actions and changes, the client's R&D, quality, regulatory, and marketing employees (yes even marketing) became more engaged as a project team, were more effectively communicating at the appropriate times and delivering the objective evidence that the regulatory authorities needed to clear and approve their device. Ongoing product improvements after the product was released to market were executed more predictably, and the higher risk design changes were subjected to a more rigorous verification and validation test plan and design transfer process (thus minimizing the potential for a recall).

RQMIS saved the client time, money and resources.

Is your quality system slowing you down?

Integrating and aligning your design control and risk management process can save you time and money.

Contact RQMIS at, call (978) 358-7307 or just click the Contact button below.


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