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3 min read

The 5 Things Medical Device Companies Need to Know about ISO & FDA Requirements

By Peter Hargittay on Tue, Apr 16, 2019 @ 06:00 AM

Medical device companies, above all else, have one thing in common – regulatory compliance. Every one of the companies in the industry must comply with ISO and FDA requirements in order to stay in business.  And these requirements are here for a very important reason - to protect the patients and consumers while ensuring the quality of products created.

Topics: quality regulatory FDA ISO FDA regulations FDA compliance new regulations iso compliance fda standards
3 min read

3 Compliance Issues That Can Be Solved By Automation

By Romeo Elias on Mon, Jul 16, 2018 @ 01:31 PM

 

Topics: Compliance workflow automation business automation Document Control CAPA automated solutions mobile compliance FDA compliance iso compliance laboratory compliance
3 min read

Mobile and FDA Compliance: New Regulations in 2018

By Romeo Elias on Tue, Jun 19, 2018 @ 02:00 PM

Things change very fast in the world of mobile apps. Besides the mobile phone manufacturers adding better cameras, processors, accelerometers, and gyroscopes; mobile app developers are following those upgrades up with new and improved apps. When talking about mobile medical apps, you probably wondered if the FDA regulates them. The answer has been changing, and we will present some of the latest rules brought by the FDA to make the picture somewhat more transparent.

Topics: mobile applications mobile apps Regulations FDA mobile compliance FDA regulations FDA compliance new regulations