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.
Drug stability reporting is an integral part of pharmaceutical product compliance. For both the development of new drug products and the required annual monitoring processes, ensuring stability reports are done thoroughly and in a timely fashion is key. Quality is also important; the fidelity and integrity of all the data generated from drug stability studies and aggregated into your reports can impact your organization’s ability to market your drug products.
Implementing a critical-to-quality (CTQ) program in your life science organization’s product development process can be a valuable effort. Identifying CTQ requirements and working through both CTQ Flowdown and Flowup activities can lead to more robust, well-made products that meet your user needs.
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There was a lot happening at FDA during May 2019. As we’ve already discussed on the blog, CDRH’s new Office of Product Evaluation and Quality is now up and running. Besides this big piece of news, there are some other FDA stories worth catching up on this month.
Many life science organizations treat design thinking and design controls as separate product development stages. In reality, they can overlap; while this feels counterintuitive to some, it’s actually an important point that teams need to manage. For a more robust product development process, your teams should be thinking about how to use these two aspects of product development together. How design thinking can impact design controls is valuable to understand and evaluate as part of your organization’s plans for long-term growth.
The pace at which news travels nowadays makes it difficult to keep up with the latest life science industry trends. However, here are some great resources that we think are worth your attention.
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.
After participating in and sponsoring the INCOSE Healthcare Working Group’s 5th Annual Systems Engineering (SE) in Healthcare Conference, we wanted to take some time on our blog to reflect on our experience, as well as share some of the things we learned.
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.