In 2003, the [...] Read More
Outsourcing and the Device Manufacturer’s QMS Accountability
August 6th, 2015 by Henry MacartneyA 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
Deciphering the FDA Medical Device QSR
May 1st, 2015 by Henry MacartneyAs a medical device manufacturer, how [...] Read More
How Compliant Are You with 21 CFR 210 / 211?
April 23rd, 2015 by Zuhdi HusseinYou know which rules [...] Read More
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 is to delay the launch of your [...] Read More
The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making
April 7th, 2015 by Zuhdi HusseinGxP-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