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How to Ensure Your Firm Meets FDA Compliance Guidelines

February 25th, 2014 by James Francum

FDA compliance is obviously a pertinent issue for many life sciences firms. In. [...] Read More

Posted in Quality Management Systems

What Goes Into Quality Assurance For Medical Devices

February 20th, 2014 by James Francum

Quality assurance (QA) isn't something implemented solely for consumer. [...] Read More

Posted in Medical Device Quality Assurance

The Dangers of Relying Solely on General Guidelines to Perform Software Validation for FDA Compliance

February 18th, 2014 by James Francum

The FDA has established, via the issuance of General Principles of Software. [...] Read More

Posted in GxP CC

How Does ISO 13485 Affect Your Company's Ability to Do Business?

February 13th, 2014 by James Francum

Although medical device manufacturers have to adhere to a number of pertinent. [...] Read More

Posted in Medical Device Validation

Is Seeking Outside Consulting Advantageous In The Medical Device Industry?

February 11th, 2014 by James Francum

The manufacture and sale of medical devices, be they intravenous catheters or. [...] Read More

Posted in Supply Chain Management

Demystifying FDA Corrective and Preventive Actions

February 6th, 2014 by James Francum

Regulations outlined in FDA CFR 21 state that manufacturers must implement and. [...] Read More

Posted in GxP CC

Why Is FDA 21 CFR Part 11 Compliance Important?

February 4th, 2014 by James Francum

Complying with Part 11 can be a difficult thing to do. This is in part due to. [...] Read More

Posted in GxP CC

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