21 CFR Part 11 - Methodsense, Inc

February 9, 2015
By Rita King
FDA 21 CFR Part 11, FDA 21 CFR Part 820, FDA Compliance

Meet FDA Requirements

Meet FDA Requirements for Medical Device Company Compliance Most medical device executives know they need FDA clearance to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively commercialize a medical device product means adapting to industry and legal expectations for operating as a medical device company. These expectations...

How to Structure a Medical Device Company

January 28, 2015
By Rita King
FDA Compliance, Medical Devices, Quality Management, Risk Management

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation....

July 29, 2014
By Rita King
FDA 21 CFR Part 11, FDA Compliance, IEC 62304, Quality Management

Medical Device Data Systems and Data Integrity

Time to Take a Closer Look at FDA MDDS Moves The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify the data, and it does not...

August 9, 2012
By Rita King
FDA Compliance, Quality Management, Risk Management

Tag: 21 CFR Part 11

Meet FDA Requirements

How to Structure a New Medical Device Business

Medical Device Data Systems and Data Integrity

Life Science Cloud Vendor Selection Part 2