Feb 12, 2015 | FDA 21 CFR Part 820, FDA Compliance, Quality Management
An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company complies with applicable laws and regulations. These regulations, such as Quality System Regulation 21 CFR... 
Jan 28, 2015 | FDA Compliance, Medical Devices, Quality Management, Risk Management
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.... 
Aug 9, 2012 | FDA Compliance, Quality Management, Risk Management
Technology Strategies to Ensure Benefits and Mitigate Risk Options to Discuss with your Life Science Cloud Vendor Cloud computing is defined to have several deployment models, each of which provides distinct trade-offs which are migrating applications to a cloud... 
Jul 30, 2012 | FDA 21 CFR Part 11, Life Science Software
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...