Industry Perspectives - Design & Development
Medical Device QMS Cybersecurity: Threat Modeling
The FDA considers threat modeling fundamental in your premarket submission and expects you to include system level risks in its creation and deployment. But how do we go about threat modeling for our device? And how do we build the requisite QMS infrastructure and processes? This article shares a four-step strategy.
New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.
How To Close The Looming Life Sciences Data Storage Gap
Organizations across life sciences are facing a data storage dilemma: how to balance the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership.
5 Steps To Eliminate Weak Links In Your Data Governance
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
FDA Vs. Congress: The Software Showdown
September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016.
You Have A Medical Device Proof Of Concept. Now What?
No matter what the medical device in development, the first major milestone is usually proof of concept. How do you go from a build-of-one device to something you can manufacture reliably and at scale? This article shares key considerations in engineering and design, quality systems, and more.
3 Steps For A Smarter Medtech Supply Chain
Our medtech industry has a huge opportunity to make our supply chains “smarter" by making the most of digital technologies and data. But we need to work in an agile manner to adopt and scale technology. This article shares three main steps to take.
cGMPs For SaMDs
Unlike traditional medical devices, software as a medical device (SaMD) can blur the lines between the design and development stages and the production aspect of commercialization. So, what are the activities necessary for medtech manufacturers to be compliant with the traditional cGMP framework?
Medtech Cyber-Incidents: A Costlier Problem Than You Think
Harnessing advanced computing technologies gives medtech companies almost unlimited profit opportunities, but it also comes with almost unlimited liability from cyber-attacks. This article discusses different harmful events and their costly ramifications to your medtech company. Don't be underprepared for a cyber-attack.
ISO 8655:2022 “Piston-Operated Volumetric Apparatus” FAQs
Read the FAQs and learn, for example, what the revision of ISO contains and the differences with the previous version.