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Design Controls have been an FDA Quality System Regulation since 1997. Having worked on developing products in the regulated medical device industry for over 35 years, I have compiled a list of the five key takeaways for implementing design controls and achieving success in commercializing medical devices: Design Controls not only help achieve regulatory compliance, […]
Incorporating Design Controls can be a daunting task for medical device product development teams. For a variety of reasons, including unfamiliarity of regulatory expectations, inexperience with implementation, or viewing them as a burden preventing innovation, too many teams incorporate Design Controls reactively instead of proactively. Here are three ways to proactively and practically incorporate design […]
Over the last decade, digital health solutions have become increasingly important, powering revolutionary developments in areas such as robotics, genomics, diagnostics, patient/provider interactions, and many more. In our recent webinar with MDM Engineering Consultants and BeanStock Ventures, we talked about critical standards and best practices to follow. Attendees also heard critical insight from industry leaders […]
Behind every successful product and product launch lies a complicated process that can involve multiple oversight agencies, cross-functional teams, and stakeholders. Within an organization’s governance, risk management, and compliance (GRC) framework, product teams must pursue market innovation while remaining in compliance. Staying in compliance with the vast array of rules, procedures, and contract clauses that […]
If you haven’t already, check out Part I of our ASPICE 101 blog series to learn about what the standard is and why it’s important to automotive development, and Part II, where we examine the similarities and differences between ISO 26262 and ASPICE. In this post, we take a look at the goals of ASPICE and […]
If you haven’t already, check out Part I of our ASPICE 101 blog series to learn about what the standard is and why it’s important to automotive development. In this post, we take a look at ISO 26262 vs. ASPICE and examine the similarities and differences between these two important automotive standards. ISO 26262 vs. […]
Machine Learning in Software as a Medical Device Machine learning (ML), a subset of artificial intelligence, has become integral across software in all industries, and the medical and life science spaces are no exceptions. ML can help medical systems improve the identification and diagnosis of disease, create personalized medicine, and help with drug discovery and […]
If you’ve worked in product development for any time at all, you’ve probably heard the term “ISO” used in conjunction with the terms “standards” and “compliance” (along with a variety of four- and five-digit numbers). But what does that all mean, and how does it affect you? In this article, we will provide you with […]
The medical device market in Europe is growing fast and is expected to reach $61.4 billion by 2025, up from $48.9 billion in 2020. A large aging population, demand for more surgical procedures, and technological expansion are driving this trend. The Medical Device Directive (MDD) is a legal framework that includes three directives that are […]
Editor’s Note: This posts on EU MDR was originally published here by MedTech Drive and written by Greg Slabodkin. Dive Brief: While the Medical Device Regulation’s May 26 go-live date marks a significant milestone, MedTech Europe warned in a statement that MDR challenges remain, limiting the industry’s ability to “seamlessly supply certified devices under the new rules.” The European trade […]