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.
Life science product development is all about process: to ensure safety and effectiveness of your product, processes must be in place to maintain high quality in your design and development work. In smaller organizations, these processes and procedures can be fairly easy to control and manage. However, as your business grows, so do the scope and complexity of your development activities. To maintain and improve your life science product development processes, there are a handful of methods your organization can undertake.
Managing multiple disciplinary teams to generate design data and documents for premarket submission and the actual production, servicing, and overall life cycle of your life science product is a big enough challenge already. When you have to manage that data across multiple, global worksites, the challenge becomes more complex.
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The input of users and patients is vital in life science product development. Yet how these inputs are understood and evaluated differs based on the information being sought out. An interesting subset of patient inputs is what’s known as patient preference. For life science organizations attempting to build innovative, patient-focused products, it’s important to understand what patient preference is, how regulatory bodies view it, and why it matters.
A familiar issue to most life science organizations is compliance—making sure your products and services meet the regulatory requirements necessary for clearance to market. Especially for growing businesses, ensuring compliance with things like design controls can prove to be a real challenge. To improve your teams’ efforts with design controls compliance, here are some quick tips to employ in your organization.
In March 2019, FDA’s Center for Devices and Radiological Health (CDRH) began their reorganization initiative first announced the year before. The Center has taken a major step forward in this process by launching the Office of Product Evaluation and Quality (OPEQ) in May 2019. With this new office, a number of important changes begin taking place at CDRH.
Implementing a robust risk management program into your life science organization requires a solid understanding of your needs, capacities, and goals. Whether to improve alignment with regulatory requirements and standards or adjust your overall risk procedures, identifying what you can do to bolster your current risk management programs is vital to promoting long-term growth. There are many ways out there to improve your risk management, but there are a few worth using as a baseline to build on.
Between a redesign of their website and a number of different actions undertaken related to patient safety concerns, FDA had a lot going on April 2019. Here are a few key highlights of this month.
Over the past few years, life science organizations have produced and marketed more products and services intended for mental health treatment. While certainly not a novel effort by the industry, the increased pace reflects cultural, economic, and scientific shifts that are changing the way we view and treat mental illness. For many organizations joining this new wave, the territory is unfamiliar and uncertain. However, there are a few baseline concerns that, once understood, can help development teams push for products meant to treat mental illness.
Coming up with the design inputs for your life science product is not an easy task; your teams need to make sure their scope and applicability are appropriate in relation to the needs of your users and patients. But before you get to that point, you have to first generate the ideas and insights that will become those design inputs. Where do you find this data?