As a medical device manufacturer, how do you identify your compliance. [...] Read More
Deciphering the FDA Medical Device QSR
May 1st, 2015 by Henry MacartneyPosted in Quality System Regulation
How Compliant Are You with 21 CFR 210 / 211?
April 23rd, 2015 by Zuhdi HusseinYou know which rules you're responsible for following, but is that enough?. [...] Read More
Posted in supplier audits
Medical Device Compliance: Recovering from FDA Warning Letters
April 21st, 2015 by Henry MacartneyYou've received one of the dreaded FDA Warning Letters. The last thing you want. [...] Read More
Posted in Medical Device Compliance
How Cybersecurity Impacts Device Producers
April 9th, 2015 by James FrancumThe FDA can be slow to change its ways, but its guidelines aren't immutable. As. [...] Read More
Posted in quality management devices
The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making
April 7th, 2015 by Zuhdi HusseinPharmaceutical manufacturers can't sell their products without first convincing. [...] Read More
Posted in Prescription Drug Users Fee Act
How Do Medical Device Manufacturers Maintain Data Integrity?
April 2nd, 2015 by Henry MacartneyIs cybersecurity something you consider when designing a new product? As. [...] Read More
Posted in FDA & European Regulations
Will 21 CFR 11 Hinder My Compliance Efforts?
March 31st, 2015 by James FrancumElectronic records are complex by nature. While they ostensibly serve as. [...] Read More
Posted in FDA regulations
What Should Drive Your FDA Medical Device Compliance Efforts?
March 27th, 2015 by Zuhdi HusseinHow do your compliance efforts impact the profitability of the goods you. [...] Read More
Posted in FDA Medical Device Compliance
Deciphering EU Cybersecurity Plans and Policies
March 25th, 2015 by Henry MacartneyBy default, your desire to market products in Europe makes EU cybersecurity. [...] Read More
Posted in governance techniques
GxP-CC Completes GMQA's Electronic Data Integrity Certification Training
March 3rd, 2015 by James FrancumTeam members of GxP-CC consultants have completed the full session of the Data. [...] Read More
Posted in Monica Cahilly
