WE OFFER YOU A QA MANAGER THAT MEETS ALL REQUIREMENTS
Our reliable QA/RA specialists maintain and manage the quality management of your company in a holistic manner by taking care of regular quality checks and participating in the weekly operations of various stakeholders.
THE DUTIES OF A PERSON RESPONSIBLE FOR QUALITY CAN BE TAILORED TO SUIT YOUR NEEDS.
Many of our clients have outsourced all QA Manager tasks to us. In this case, our work proceeds according to the annual calendar.
WE TAKE CARE OF
timely internal and external audits
notifications and documentation in potential error situations
monitoring clinical investigations and many other product development and manufacturing processes.
Our QA Manager often takes care of the company’s PMS (post-market surveillance) and PMCF (post-market clinical follow-up) processes as well as updating the clinical evaluation (CER) regularly.
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)
All MDS specialists fulfill the requirements of the mandatory person responsible for regulatory compliance (PRRC).
WE CAN LEASE YOU A PRRC SPECIALIST WHO COMPLETES YOUR TEAM.
The PRRC is responsible for ensuring that your company has the latest information about the legislation and the requirements referred to in the IVD and MDR. The PRRC will often participate in your company’s normal activities, such as internal and external audits and subcontractor audits, and can implement independent reviews in various areas, such as GSPR lists.
If necessary, we will take care of communications with the Notified Body and Competent Authority.