R E G U L A T O R Y    C O M P L I A N C E  

for medical devices, IVD devices and drug-device-combination products



Compliance app for medical devices

We bring more than 20 years of project experience into this app.

Our mission is to reduce drastically the workload for generating the documentation for medical device approvals.  

The aim of medifiler is to make regulatory file submission easy and efficient - without confusing spreadsheet design and useless templates.

MDR & IVDR 

medifiler is a software tool that helps you to collect all information you need for compliance with regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR).







 

M e d i c a l   D e v i c e s

 


 

I n  V i t r o  D i a g n o s t i c

 


 

D r u g  D e v i c e  C o m b i n a t i o n s

 






medifiler MD is a software solution that supports the product approval of medical devices to achieve compliance  with MDR requirements.


medifiler IVD is a software solution that helps legal manufactures to achieve approval of in vitro diagnostic medical devices under IVDR requirements.


medifiler DDC is a software solution that can be used to provide sufficient compliance evidence for the MDR article 117 for drug-device combinations.