Insights for FDA Regulated and HIPAA Compliant Organizations
Navigating Changing Regulations for Diagnostic Companies
As US-based diagnostic organizations capitalize on the increasing world-wide interest in testing, they need to understand the regulatory landscape in different markets.
The European Union's (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements.
The biggest change is the introduction of a risk-based approach to classification in addition to increased NB oversight.
Learn how TAGmedica and our partner Titan Solutions are addressing these challenges and creating successful outcomes for our clients by checking out our article IVDR: What You Need to Know about Europe's Changing IVD Market