Medical Device Manufacturers Warned for CAPA Noncompliance
Large Image Caption
Having a CAPA process doesn’t necessarily mean that it is functional.
Fostering Medical Innovation
Large Image Caption
According to one estimate, last year there were 165,000 health-related apps available for Apple or Android smartphones.
The Sugary Drink Tax
Large Image Caption
A way for sugary-drink manufacturers to sweeten the bottom line
What Are ISO 13485:2016 Validation Requirements?
Large Image Caption
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
Large Image Caption
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
Large Image Caption
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
Large Image Caption
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?
Large Image Caption
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
Large Image Caption
The Center for Devices and Radiological Health (CDRH) puts a premium on quality for medical devices
