Person Responsible for Regulatory Compliance MDR 2017/745 requires that all manufacturers have a PRRC at available at all times. There are clearly defined requirements to the education and regulatory/quality assurance experience of the PRRC and to the responsibility. The PRRC is responsible for: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under …

Quality-Audit offers medical device consulting to help companies achieve and maintain compliance to regulations and standards by providing indepent assessment and services. The Medical Device industry is regulated by ever-increasing compliance and regulatory requirements. The increasing demands are intended to strengthen patient safety and to ensure adequate accessibility of medical devices. The goal is better patient safety in all respects. …

As a former Lead Auditor for a Notified Body, with experience from over 50 NB audits, Quality-Audit can support you with the following audit services. Mock audits, Internal audits, Supplier audits, Due diligence audits Compliance to the following audit requirements can be covered during the audit(s): Medical Device Regulation (EU) 2017/745 MDSAP EN ISO 13485:2016 EN ISO ISO 9001:2015 FDA …