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How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by

Pharmaceutical ManufacturingYou know which rules you’re responsible for following, but is that enough? Agencies like the FDA rarely make exceptions for firms that misinterpret the law, and although you may be able [...] Read More

Medical Device Compliance: Recovering from FDA Warning Letters

April 21st, 2015 by

FDA Warning LetterYou’ve received one of the dreaded FDA Warning Letters. The last thing you want is to delay the launch of your company’s [...] Read More

How Cybersecurity Impacts Device Producers

April 9th, 2015 by

Laptop & StethoscopeThe FDA can be slow to change its ways, but its guidelines aren’t immutable. As new technological concerns arise, the agency adapts its suggestions on how medical device manufacturers should respond, and [...] Read More

The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making

April 7th, 2015 by

FDA RegulationsPharmaceutical manufacturers can’t sell their products without first convincing regulators of their safety. Firms that fail to do so sustain fiscal losses when they [...] Read More

How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by

Data IntegrityIs cybersecurity something you consider when designing a new product? As medical devices become more and more interconnected, the data they generate, store and share becomes more [...] Read More