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, […]
This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants. SaMD software is software intended to be used for one or more medical purposes that do not require embedding in a medical device. These purposes can range anywhere from helping to diagnose or […]
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 […]
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 […]
Editor’s Note: This posts on lessons learned around medical device development during COVID 19 was originally published here by MedTech Intelligence and written by Josh Turpen, Jama Software’s Chief Product Officer. In the fall, I wrote about how the medical technology industry has struggled to keep pace with other, similar industries. In the piece, I discuss how important it is […]
What is FMEA (Failure Mode and Effects Analysis)? Failure Mode and Effects Analysis (FMEA) is a structured process for determining potential risks and failures of a product or process during the development phase. FMEA teams examine failure modes—those potential points of failure in a product or process — and what the failure effects (risks, harm, […]
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
Implementing Jama Connect has improved traceability and test management for Finnish Red Cross Blood Services and improved team efficiency.
In this post, experts explain why a keen focus on quality is the top trend for medical device development in 2021, and how teams can prepare.