Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Does your life science organization need to adopt a compliance software tool?
NAVIGATE2019 is coming up September 5-6 at the Marriott Long Wharf Hotel in Boston, Massachusetts. We’re excited for the incredible lineup of talks and presentations this year, and we hope you’ll join us. If you’re curious about what you’ll see and learn about this year, then you’re in luck! Here’s a preview of just a few of this year’s presentations.
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Many organizations tend to stick with what’s worked for them in the past for regulatory compliance due to its complexities and the need to assure that new products are safe and effective. This is especially true when it comes to compliance activities such as design controls. While this attitude is understandable, it does present some problems. It can limit an organization’s ability to remain competitive in the market, and it can also impede long-term business growth.
We’re halfway through the regulatory year, and there’s a lot we could cover in the July 2019 edition of the FDA Pulse Check. Here are a handful of important updates we think are worth keeping tabs on.
In July 2019, Ed Margerrison and Hilda Scharen of CDRH released information on FDA Voices about how the agency is working to increase the pace of medical device innovation. By using sound science and proven methodologies, FDA plans to work with device manufacturers to get beneficial products to market faster.
FDA’s Design Controls regulation can be an open book but sometimes hard to read. Interpretations of the various regulatory requirements contained within 21 CFR 820.30 can vary both between and within life science organizations. The challenge becomes interpreting the requirements and implementing them into your development processes in such a way that does not negatively impact product quality or your larger quality system.
FDA’s Design Controls regulation has no clear mandate as to the purpose of design reviews. Rather, they are concerned with seeing evidence these reviews are conducted at regular intervals by appropriate parties. Determining what data comes out of a design review is ultimately up to your organization’s needs and objectives.
Compliance from the start—why make it a priority in life science product development?
In life science industries, many believe that regulatory inspections are focused more on postmarket activities. This attitude isn’t surprising; however, its results can be detrimental. Many companies elect to focus on bolstering their postmarket compliance, allowing other regulatory activities such as design controls to lapse or deteriorate over time. Unfortunately for these companies, the truth about regulatory inspections is starkly different than their beliefs, and that can come back to haunt them.