What Are ISO 13485:2016 Validation Requirements?
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Validation of computer systems is a legal requirement within a number of life science industries,
including ISO 13485
Dual Status Hospitals: Beware of IRS Compliance Audits
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The IRS is ramping up compliance audits of governmental hospitals who are exempt under 501(c)3 (dual status).
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
Beyond Just Promise, CRISPR Is Delivering in the Lab Today
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Research labs around the world are turning the hype surrounding the CRISPR technique into real results
Medieval Medical Books Could Hold the Recipe for New Antibiotics
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A recipe for an eyesalve from Bald’s Leechbook (© The British Library Board, Royal MS 12 D xvii)
How Will Real-World Evidence Affect 2017 FDA Guidances?
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The`Advanced Medical Technology Association has asked the FDA to clarify how real-world examples support regulatory decision making
Quality Management Insights for Medical Device Manufacturers
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The Center for Devices and Radiological Health (CDRH) puts a premium on quality for medical devices
PRISM Identifies Vaccine Safety Issues
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PRISM is a computer-based vaccine safety monitoring system that sifts out critical information
FDA: Helping Small Businesses Get Big Results
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Small companies have a significant impact on U.S. made pharmaceuticals
It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.
Inside Quality Digest Live for April 14, 2017
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Expect to see e-skin devices in the near future
Credit: University of Tokyo, School of Engineering
On our most recent episode of QDL from this past Fri., April 14, 2017, we took a close look at innovation and engineering. Here’s a quick recap: