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 Company than IP and R&D Most emerging medical device companies tend to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced... 
Aug 9, 2012 | FDA Compliance, Quality Management, Risk Management
Categories Company News (1) FDA 21 CFR Part 11 (2) FDA 21 CFR Part 820 (3) FDA Compliance (14) Human Factors (2) IEC 60601-1 (1) IEC 62304 (5) IEC 62366 (2) ISO 13485:2016 (2) ISO 14971 (1) Life Science Software (3) Medical Devices (8) Quality Management (9) Risk... 
Jul 30, 2012 | Quality Management, Risk Management
Categories Company News (1) FDA 21 CFR Part 11 (2) FDA 21 CFR Part 820 (3) FDA Compliance (14) Human Factors (2) IEC 60601-1 (1) IEC 62304 (5) IEC 62366 (2) ISO 13485:2016 (2) ISO 14971 (1) Life Science Software (3) Medical Devices (8) Quality Management (9) Risk...