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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.

How can you save time and money through product development?

Aligning the Design Control and Risk Management processes can be very challenging. Companies have to ensure that they are producing the necessary product specifications, standards compliance and testing to demonstrate that they have developed a safe and effective medical product, but also that they're satisfying regulatory authorities around the world. To do this efficiently is an even greater challenge.

If a company is focused only on complying with their internal requirements but not those of the regulatory authorities, they can see significant delays to market, increased costs to the development phase, or ultimately risk gaining market clearance for their product. Companies must be able to integrate these requirements to develop a medical product that more effectively satisfies the customers, both patient and regulatory authorities, which will also allow them to develop that product at a lower cost.

The reality of this is clearly seen when companies change their medical device designs after the products have been released to market. Medical device companies often engage in continuous updates to designs based upon field use and recommendations from customers. While some of these changes may be minor, others are much more significant. Those more significant changes will result in the need for additional regulatory submissions - 510(k), PMA Supplements, and so on. Is it especially important that companies have Design Control requirements applied to these changes.

THE SITUATION

A US manufacturer was getting frustrated by the long product development cycles of their Class II and Class III medical devices. Due to this existing frustration, their response to required design changes after market release was often less than robust: "We didn't know FDA would require this test" or "The regulatory department told us about this requirement after the project was 80% complete". Unfortunately, the FDA was not amused by these excuses.

THE SOLUTION

To aid this client and help ease their frustrations, RQMIS:

  • 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 processes
  • Redesigned the Design Control and Risk Management processes, including the effects of these changes to the Change Control process
  • Ensured 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 successfully 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 info@rqmis.com, call (978) 358-7307 or just click the Contact button below.

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