MDR/IVDR Consultancy (CE, UKCA, MedDo)

Medical Device Registration (EUDAMED, MHRA, MedDo)

PRRC Services in Israel

We create compliance for safer markets!

  Cyber Security system by ISO  27001 & 27799

  Technical Documentation compilation

Person Responsible for Regulatory Compliance (PRRC)

  Medical Device Registration in  ISRAEL

  QMS system by ISO 9001 &13485

Why to choose Obelis Group & SYNC Projects?

Obelis Group and SYNC Projects are working towards the same goal, “creating compliance for safer markets”. As of February 20, 2022, SYNC Projects Ltd. has been acquired by Obelis Group, allowing us to expand our operations to the Israeli Market, in addition to the European Union, United Kingdom (UK) and Switzerland. 

This collaboration enables us both to fortify the market's safety while delivering top-quality services and expertise. Manufacturers of Medical Devices, In-Vitro Diagnostic Devices and Cosmetics in Israel can now benefit from the security of selling fully compliant and safe products, supervised by the joint expertise of Obelis Group and SYNC Projects’ professional regulatory consultants.

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Obelis Group is a quality-driven, service-oriented company based in Brussels, Belgium. With 34 years of experience, we are one of the largest regulatory centers in Europe, and we have been providing EC REP and RP services to more than 3.000 manufacturers from all around the world. We are ISO 9001 & 13485 Certified! 

SYNC Projects has 20 years of experience providing regulatory and quality services, assisting companies with the regulatory and quality aspects, and specializes in developing company-tailored quality and regulatory strategies for medical devices & cosmetics. The team is composed of experts keeping track of all Israeli standards and regulatory updates, providing the most effective solutions to all challenges.