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How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by Zuhdi Hussein

You 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 Macartney

You'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 Francum

The 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 Hussein

Pharmaceutical 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 Macartney

Is cybersecurity something you consider when designing a new product? As. [...] Read More

Posted in FDA & European Regulations

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