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...
Documents, documents everywhere. But which are the records, which are documents—what is the difference and why does it matter? Even start-up medical device companies are neck deep in documentation. In addition to documents generated during the creation and production of a product or combination device, additional documentation is generated while working with the FDA Q-Subs,...
How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-UpQuestionnaire: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic signatures, have you thoroughly assessed their function for 21 CFR Part 11 compliance? Do your documentchanges...
This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations need to...
We are pleased to announce that CEO Rita King was named “Healthcare CEO of the Year – USA” by Business Worldwide Magazine. Full text of the press release is below… LONDON, October 4, 2018 /PRNewswire. The chief executive of life science consulting firm MethodSense has gained global recognition for outstanding leadership in the Business Worldwide Magazine...
The tech world is exploding around the realities and possibilities of Artificial Intelligence (AI). Artificial Intelligence makes it possible for machines to learn from experience, adjust to new inputs and perform human-like tasks reflecting what we normally think requires natural intelligence. There are currently relatively few FDA cleared products that use Artificial intelligence on the market. But...
Ensuring a FDA 510(k) submission is done properly is critical to getting your medical device into the market and monetizing your development. And the speed with which you complete your submission can drive significant business value. Timeliness is key, as is completeness and accuracy. This is the business value we seek to bring to our...
MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees...