With only a few months left until the date of application for MDR, the pressure on quality and regulatory work is increasing for all actors. Update and review of the technical documentation, clinical evaluation, defining the role of Person Responsible for Regulatory Compliance (PRRC), UDI implementation and quality audits are all a huge teamwork effort.
MDR and IVDR are not the only updated regulatory requirements that need to be implemented. Revised standards, guidelines and other global regulatory requirements are also being published continuously. For example manufacturers placing devices on the UK market, need to appoint a United Kingdom Responsible Person (UKRP) from 1st Jan 2021.
Several manufacturers have now achieved their MDR certificates and a consensus on interpretation issues is beginning to be established. QAdvis is prepared and dedicated to support you with the MDR and IVDR challenges and opportunities ahead.
This technical report contains concrete product requirements to be implemented both in devices with embedded software and Software as a Medical Device (SaMD). Read more here.
How to ensure a robust regulatory Due Diligence
A probable consequence of the new regulations is an increased number of mergers and acquisitions (M&A). A well performed due diligence process is challenging but crucial in any M&A decision or investment planning.
#1. Be specific with the scope definition
#2. Ensure efficient communication with all parties
#3. Base your decisions on objective evidence
Strengthening your due diligence team with QAdvis medical device quality, regulatory and clinical experts will significantly increase the chances of a successful project.
If you have any questions about our newsletter, please feel free to contact Hermine Redl, Office Manager, by phone on +46 8 621 01 05 or email here.
Meet our QAdvis Senior Quality and Regulatory Consultant and appreciated IVDR course leader, Anna-Karin Areskog.
What is your area of expertise within the Medical Device industry?
My expertise is wide, I have worked with QMS, QA, QC, Validation and RA issues for over 20 years. If I must choose, I say my expertise is QA for the producing industry.
What is your best quality in your work as a consultant?
I am a listener and problem solver and my goal as a humble consultant is to ensure that the regulatory and customer requirements converge in a combination that can be used in a value-adding way.
If you can only pick ONE piece of advice to give to your client, based on your expertise, what would it be?
Use regulations with common sense together with a risk based approach.
Where do you find recovery in your everyday life?
Walking with our dog and spending time with grandchildren is my way of regaining strength for the next day.
I look forward to meeting you in our IVDR-course in April.