We offer 2 types of services to support medical device manufacturers in ISRAEL to comply with the requirements of the MDR/IVDR:
Outsourced Person Responsible for Regulatory Compliance
Outsourced Consultant to support your PRRC
In both cases, SYNC Projects we will provide you with a competent consultant who is knowledgeable in the field of Medical Devices, skilled and experienced in quality and regulatory affairs, well acquainted with the regulatory requirements and in case of a PRRC, meets the pre-requisites of the MDR and the IVDR.
As PRRC, the designated consultant will review and improve the existing SOPs and ensure the devices are manufactured in accordance with the relevant quality management system while being in conformity with the requirements of the MDR/IVDR. The Technical Documentation will be reviewed or compiled allowing the manufacturer to sign the EU declaration of conformity. The designated PRRC will be continuously and permanently available to support the manufacturer during announced and unannounced audits.
With the support and coordination with the PRRC at the side of the Authorized Representative, Post Marketing activities and incident reporting will be handled to meet the requirements of the MDR/IVDR
As Consultant to the PRRC, we will support the manufacturer PRRC to create an annual plan, which will guide him in carrying out the PRRC tasks. To reach that objective we will remain available, and make sure to provide ongoing support to every issue that might arise.
We are here to provide our clients with personalized PRRC service. Contact us to see which of our services best meet your needs.