You know which rules you're responsible for following, but is that enough?. [...] Read More
How Compliant Are You with 21 CFR 210 / 211?
April 23rd, 2015 by Zuhdi HusseinPosted 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
