Planning and reporting according to IVDR 2017/746 from Class A to Class D.
Efficient continuous process of post-market surveillance for IVDs and medical devices.
Discuss your regulatory (MDD / MDR), developmental or strategic questions with our experts.
Do we really need a study? If so, how should our study look like, what are the best endpoints and where should we conduct it?
Professional literature searches by expert medical writers on new technologies, indications, targets, and more.
Receive 2nd opinions from industry veterans and gain confidence on strategic and scientific decisions.
Consultancy & software development
Learn more
Actually acting
Get inspired
Introducing company management
I'm curious
For over two decades, we've assisted medical device manufacturers of all sizes with regulatory approvals and post-market surveillance in the EU, USA, and China.
Clinical evaluation
Thorough analysis of medical device performance & safety in a CEP and CER.
Biological evaluation
Comprehensive analysis of device-material interactions in a BEP and BER.
Post-market surveillance
Ensuring ongoing safety & effectiveness of medical devices.
Toxicological expert statement
In-depth analysis of potential toxicological risks.
Summary of safety and clinical performance
Combining safety data & clinical outcomes for informed decisions.
Publication writing
Expert writing for impactful medical publications.
Drug-Device combination products
Navigating complexities of drug-device combination products.
Literature searches
Focused literature searches tailored to specific inquiries.
DiGA applications
Providing expert knowledge and documentation for DiGA applications.
PFAS in medical devices
Toxicological assessment and regulatory support for PFAS.
Ad-hoc & micro consultancy
Efficient ad-hoc and micro consultancy for medical devices since 2004. Tailored solutions for quick, precise insights. Your challenges, our expertise.
Mühlenstr. 23C 52832 Niederzier, Germany
+49 (0)2428 8096-44
info@iasonconsulting.com
