Data Integrity - Methodsense, Inc

FDA to Create a Digital Health Unit

The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital...

Colliding Cultures: Software Development and the Medical Device Industry

Part 1 – Medical Device Software, the FDA and the US Congress Preface: In any given 2-week period, an average of 15% to 20% of the applications on my smartphone have new versions to fix software bugs. Others I speak with experience similar statistics. And, that doesn’t include how often my smartphone software crashes while...

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Time to Take a Closer Look at FDA MDDS Moves The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS).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...

Cloud Vendor Selection for Life Science Companies

July 30, 2012
By Rita King
FDA 21 CFR Part 11, Life Science Software

Cloud Vendor Selection for Life Sciences

Benefits and Risks of Moving to the Cloud, Including Cloud Vendor Selection 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)...

Tag: Data Integrity

FDA to Create a Digital Health Unit

Colliding Cultures: Software Development and the Medical Device Industry

Medical Device Data Systems and Data Integrity

Cloud Vendor Selection for Life Sciences