YOUR REGULATORY CONSULTANT - OBELIS & SYNC PROJECTS

YOUR
REGULATORY CONSULTANT
(ISO 13485 -PRRC - MDR/IVDR)

YOUR
REGULATORY CONSULTENT
(ISO 13485 -PRRC - MDR/IVDR)

We are SYNC Projects – We know Regulation!
As part of our operations, we work with the Israeli Ministry of Health, Notified Bodies in Europe, Manufacturing sites around the world and other producers in the medical sector. We make sure to provide our customers with the required services to guarantee they comply with quality and regulatory processes to enable them to make their devices available on the Market whether in Israel or abroad.
Since the establishment of the company in 2004 , we have acquired a great deal of knowledge, experience and reputation in our field and we organize annually several conferences, courses, webinars and seminars in the field of Medical Devices and compliance with the MDR and IVDR.

Interested in launching your product to the EU market?

It's time to start the process

Name*

Phone number*

Email adress*

:Our services include but are not limited to the following
Creating a Quality Management system according to ISO 13485 ✓

Compilation of Technical file according to the MDR/IVDR ✓
Click for more information about the process

Assuming the role of PRRC within your organization ✓

For almost 10 years now, we have partnered with the Obelis Group to enhance the combined regulatory solutions we can provide to the Israeli medical device industry.
The Obelis Group, with over 30 years of experience on EU regulations applicable to medical devices and in-vitro diagnostics provides a turn key regulatory solution to manufacturers as:

✓ European Authorized Representative – including:
➣ EUDAMED Registration

➣ EU Device Registrations

➣ Free Sales Certificates

✓ Swiss Authorized Representative

✓ UK Responsible Person – including:

➣ MHRA registration
➣ UKCA Mark Consultancies

To know more of our combined regulatory solutions please contact us

Interested in launching your product to the EU market?

It's time to start the process

Name*

Phone number*

Email adress*