Discover about the Disposable masks manufacturing
December 28, 2020

Disposable masks manufacturing are accomplished for just one time use. These masks are worn by the health care experts during medical procedure, ...

Is Regulatory compliance strategy for medical devices effective?
May 15, 2020

A Regulatory Compliance Strategy for Medical Devices is a regularly formal report that adjusts the regulatory activities, together with the busine...

How To Integrate Usability Into Medical Devices
May 02, 2020

Integrate Usability into medical devices for a better risk based testing process that includes testing how easy simple and safe a medical device i...

Medical Device Accessories Guidance | Food Drug and Cosmetic Act
April 03, 2020

The FDA issued Medical Device Accessories –Guidance for Industry and Food and Drug Administration Staff, which applies to the Center for Device...

USFDA’s Regulation for Medical Devices Advertising and Promotion
April 03, 2020

There are thousands of Medical Devices being promoted and advertised out there. The U.S FDA Food And Drugs Administration has the l...

FDA Inspections vs ISO Audits : FDA 21 CFR Part 820 and ISO 13485
April 03, 2020

FDA Inspections And ISO Audits
As you can see there is a huge difference in inspection and audit, Audit is an independent review and examination o...

January 02, 2020

Medical Device Development :
High-risk medical devices are not easy to launch as of layers of regulations. The main purpose of launching a medical...