Blog

5 Questions to Evaluate your Records v. Documents Management Practices

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,...
Read more

Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

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...
Read more

Regulating Medical Devices Shapes Industry for the Better

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...
Read more

MethodSense Inc. CEO WiMethodSense Inc. CEO Wins Global Leadershipns Global Leadership Award with Business Worldwide Magazine

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...
Read more

Artificial Intelligence and the FDA

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...
Read more
Medical Device User Fees (MDUFA)

FDA Announces FY 2018 MDUFA Fees

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...
Read more
FDA Recognized Consensus Standards

FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Streamlines Process for Accepting Consensus Standards We are seeing the impact of the 21st Century Cures Act yet again with FDA’s clarification on how they will process requests for recognition of consensus standards. With this new policy, FDA has streamlined the process that allows medical device manufacturers to submit a request to the FDA...
Read more
This website uses cookies and asks your personal data to enhance your browsing experience.