In a recent quarterly 2015 report, the US Food and Drug Administration (FDA). [...] Read More
Premarket Submissions of Medical Devices
March 11th, 2016 by Henry MacartneyPosted in Premarket Submissions
Key Characteristics of FDA Part 11 Compliance
February 4th, 2016 by Henry MacartneyProperly managing sensitive information to maintain privacy and security has. [...] Read More
Posted in FDA & European Regulations
10 CAPA Tips for the Medical Device Industry
January 27th, 2016 by Zuhdi HusseinThe CAPA process from the side of regulatory compliance of both U.S. FDA. [...] Read More
How to Avoid Pharmaceutical Data Integrity Issues
January 22nd, 2016 by James FrancumIn 2015, the US Food and Drug Administration (USFDA) issued Warning Letters to. [...] Read More
Posted in Pharmaceutical Data Integrity
What Data Integrity Means to Device Manufacturers
August 28th, 2015 by Zuhdi HusseinData integrity is an ever-increasing concern in life sciences, with medical. [...] Read More
Posted in Quality Management Systems
The EU Influence on Medical Devices & Their Manufacture
August 20th, 2015 by Henry MacartneyExcluding the United States, European recommendations for medical device. [...] Read More
Posted in Medical Device Manufacturing Compliance
Complying with eMDR FDA Regulations
August 14th, 2015 by James FrancumIn February of 2014 the Food and Drug Administration (FDA) published the final. [...] Read More
Posted in HL7ACSR
Outsourcing and the Device Manufacturer’s QMS Accountability
August 6th, 2015 by Henry MacartneyIn 2003, the International Organization for Standardization (ISO) issued ISO. [...] Read More
A Flexible Approach to 21 CFR 820 Compliance
June 11th, 2015 by Henry MacartneyThe Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards. [...] Read More
Posted in Quality Systems Regulations
Anticipating FDA Initiatives for Risk Management
May 6th, 2015 by James FrancumRegulatory bodies like the FDA enact initiatives on a routine basis. While. [...] Read More
Posted in Risk Management
