In our previous post, “IEC 60601 and Outsourced Product Development”, we discussed at a very high level the challenges of compliance in the development of medical devices, specifically regarding IEC 60601 and its requirements for basic safety and essential performance. But safety is just one component of the compliance of a medical device. As part of our ongoing series, in this post, we will discuss managing risk and ISO 14971.
Risk management is an instrumental component of the product lifecycle. Managing risk is of paramount importance when developing medical devices to ensure positive patient outcomes as well as user safety. An outsourced product development company must understand the appropriate application of risk management methodologies to ensure a smooth submittal and approval process.
ISO 14971:2007 – “Medical devices — Application of Risk Management to Medical Devices”, requires that unacceptable risks are identified and the mitigations are implemented during the design phase. For example, ISO 14971, at a high level, endeavors to ensure that any known issues with previous devices have been avoided. In addition, the risk management files must also show that “reasonably foreseeable misuse” has been considered. For example; avoiding the use of an off the shelf connector for a specialty medical device. Labeling can no longer be used as mitigation for unacceptable risk. If an unacceptable risk is identified this must be addressed through design.
Starting the risk management process early is critical to a smooth project and paving the way for regulatory approval.
For outsourced development companies that work with medical device partners, a strong knowledge of the requirements of ISO 14971 is critical. Partners should expect the provider to understand and deliver the required documents to illustrate a strong risk management process in compliance.
Risk management is comprehensive and requires many considerations. For example, how do you address when a design review determines an unacceptable risk result from a single fault condition? Every situation is different, and determining whether the design can tolerate redundancy for additional protection, or that a higher reliability part is available and adequate, can save significant time, money and frustrations.
For companies that currently use or are considering an outsourced development partner for their medical device, be certain that the partner not only understands the requirements of risk management but also understands them at a level of detail that they can address those requirements and deliver the required level of documentation to help ensure compliance.
Resolution Development Services is uniquely qualified to partner with medical device companies developing products. With a deep understanding of the strict regulatory needs associated with ISO 14971 along with other critical regulatory requirements, Resolution provides peace of mind to their partners that the project will be done right and in compliance.
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