Risk Management - Methodsense, Inc

June 24, 2019
By Russ King
FDA Compliance, Medical Devices, Risk Management

Accessory or Component and the FDA – The Fine Line Between Them

Determining if your product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction between the two terms has long been the subject of debate and interpretation. In August 2017, the FDA began a new effort to classify a “list of [medical device] accessories...

March 28, 2017
By Rita King
Human Factors, IEC 62366

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on...

How the 21st Century Cures Act Impacts Medical Device Software

There has been a lot of discussion surrounding medical device software and how it should be regulated. Concern about software of this nature will continue to rise to the forefront of conversations because there will be an increasing number of these products in the marketplace. The 21st Century Cures Act specifically addresses which types of...

April 11, 2016
By Rita King
Risk Management

What Happens When the FDA says, “I don’t know”

The FDA is now trying to track what it’s calling “emerging safety signals.” Recently, a study found a possible link between reduced leaflet mobility in TAVRs and the incidence of stroke in the fall. When people turned to the FDA looking for insight, the agency responded with, “Limited available data do not allow us to...

Laboratory Developed Tests for Medical Devices

FDA Oversight of Laboratory Developed Tests (LDTs) is on the Horizon

How Do Laboratory Developed Tests Impact Your Business? The Office of Public Health Strategy and Analysis recently issued a report that reviewed 20 products that relied on Laboratory Developed Tests (LDTs) to determine whether a lack of oversight may have caused actual harm to patients or not. Once, LDTs were relatively simple tests that may not...

Cybersecurity – A Real Threat to Medical Devices

IEC 62304 Software Development Life Cycle

Avoid Common Medical Device Software Development Life Cycle Pitfalls

Learn Potential Software Development Life Cycle Pitfalls to Pay Attention To IEC 62304 is the international standard that defines software development life cycle requirements for medical device software. IEC 62304 was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to develop...

FDA Issues Final Guidance on Reusable Medical Devices

Endoscopes Linked to “Superbugs” Lead to New FDA Guidance for Reusable Medical Devices UPDATE The FDA has released the slides from their presentation on Reprocessing Medical Devices. Get the slides here. In light of the fatal “superbugs” that have been plaguing hospitals after using endoscopes, the FDA has released new guidance for reusable medical devices....

Don’t Forget Safety Testing and the Value of Risk Management!

Establish the Safety of Your Medical Device with IEC 60601 Compliance In our experience, the most frequently forgotten aspect of medical device development and commercialization from emerging companies is establishing a safety profile of a product. While clinical data or clinical trials may be necessary for establishing safety for some products, many Class II devices...

March 5, 2015
By Rita King
FDA 21 CFR Part 820, Quality Management, Risk Management

Implement 21 CFR Part 820 Controls Early On

Benefits and Risks of Moving to the Cloud Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly...

Tag: Risk Management