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.
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.
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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.
There are many ways to make your life science product development more productive, but these can sometimes be short-term or surface fixes. There are far deeper and more ingrained organizational issues that must be tackled in order to push your company’s productivity further. Beyond compliance or development planning, there are important initiatives your business needs to address that can change how your organization behaves in favor of greater productivity.
Cognition is again hosting our annual user conference, NAVIGATE2019, September 5-6 at the Marriott Long Wharf Hotel in Boston, Massachusetts. This two-day conference brings attendees and speakers from across life science industries to talk about the latest industry topics, successes and challenges, and the latest happening with Cognition and its products and services.
Things appear to be slowing down at FDA as summer approaches. June 2019 saw less regulatory activity than in previous months, but there are still a handful of important updates worth checking up on.
Product development in life science industries is not always consistent; it naturally ebbs and flows depending on a variety of factors, such as: project reviews, technological breakthroughs, changes in personnel, and so on. However, if your organization is struggling with being productive, some larger issues need to be addressed. To improve productivity at your life science organization, there are six different approaches you can take.
Life science organizations are continuously attempting to handle the ever-changing needs of the marketplace—especially those of users and patients. With the rising number of retiring Baby Boomers set to double Medicare and Medicaid costs by 2020, it is advantageous for organizations to build products and services that meet the needs of this population. However, shifting demographics are causing growing pains that life science organizations need to factor in for long-term stability and growth.