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3 min read

5 Tips for Successful Change Management

By Peter Hargittay on Thu, Sep 12, 2019 @ 12:14 PM

What should an effectively-designed change management app bring to the table? It should define how technologies, procedures, and strategies will be applied throughout the organization to address current changes in the business environment. For companies that want to implement a change management process for quality and compliance, it requires thorough preparation and planning. So, starting with a good strategy can help them create an adaptable change management system, which will allow them to better anticipate and plan for change (rather than reacting to it).

Topics: Regulations QMS Change Management ISO FDA regulations configurability ISO 9001 ISO 13485 flexible change management solution
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

Food Industry: Ensuring Quality and Operational Excellence

By Romeo Elias on Thu, Aug 16, 2018 @ 02:41 PM


Topics: Compliance food industry mobile compliance FDA regulations manufacturing
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