Altagena d.o.o. is a regulatory and quality (RA/QA) consultancy dedicated to supporting medical device and in vitro diagnostic (IVD) companies in meeting European requirements.

Any company that wants to place a medical device on the EU market must comply with the EU Medical Device Regulation (MDR), ISO 13485 as standard for quality management system exclusevly for medical device manufacturers, and all other applicable regulations and harmonized standards (for example, ISO 10993 family for biocompatibility, ISO 14971 for risk management for medical devices, ISO 15223-1 for labels and symbols, and so on ).

We guide manufacturers end-to-end — from the earliest device concept and intended use definition, through regulatory strategy, classification, and QMS implementation (ISO 13485), to risk management, clinical evaluation / performance evidence, and technical documentation. We also support conformity assessment readiness, interactions with Notified Bodies (where applicable), and the final steps of registration and successful placing of the device on the European market, including post-market obligations.

In addition, we actively support clients with EUDAMED manufacturer registration and implementation of Unique Device Identifier - UDI (including UDI assignment, labeling, and related documentation) to ensure full traceability and compliance. We also offer an outsourced Person Responsible for Regulatory Compliance (PRRC) service, helping manufacturers meet MDR requirements with experienced regulatory leadership. Where needed, we can also connect manufacturers with appropriate Authorized Representatives to ensure they have the right local/regulatory presence for market access.

Our experience spans a wide range of medical device categories, including non-woven drapes and gowns, neuro-robotics, disinfectants, catheters (various types), gauze and gauze-based products, dental implants and accessories, wound dressings, diapers and other incontinence products, brain recording electrodes (EEG electrodes), aspirator tips for dental surgeries, and many other devices.

We support manufacturers across multiple markets and regions, including Europe Union (e.g., Belgium, Poland), as well as Switzerland, South Africa and others.

 

Find out more about Altagena services on our global website https://altagena.hr/

 

Information:

Address:
Krežmina 1, Zagreb, Croatia 

Phone:
+385 98 941 05 94

Email:
kristina.brkic@altagena.hr

Website:
https://altagena.hr/