Preparing, managing and responding to nonconformances.
We are less than three months away from the deadline for medical device compliance to the new EU MDR regulation (EU 2017 /275), which will require compulsory assessments by your notified body to determine how well your systems comply to this new regulation.
Are you sure you're ready? We've heard loud and clear an abundance of last-minute issues and questions.
Our March 31st webinar is the premier opportunity to learn from seasoned industry and notified body experts as they share their experiences with preparing, performing, and managing audits, as well as remediating nonconformances.
While there have been and will continue to be plenty of implementation challenges with EU MDR and the expectations for audits, these R&Q Vice Presidents have worked through some comprehensive guidance on what to expect during an EU MDR audit and how to strategically prepare and manage it.
Here's a summary of topics to be covered during the webinar:
– Getting fully prepared for your notified body audit
- Are your quality systems compliant to ISO13485:2016 and the EU MDR requirements?
- Do you have adequate staffing to plan for the audit and an established process to manage it?
- Training on how to interact with auditors
– Managing the audit
- Have you established the strategy to actively manage the audit: The Notified Body audit plan provided in advance, who will manage the auditors, SMEs to cover specific areas and topics?
- What to expect during the audit.
– Responding to audit nonconformances
- Does the organization understand the expectations from your Notified Body regarding the resolution of nonconformances?
- How will you internally manage the response to the Notified Body and assure it adequately addresses the nonconformance?
If you want guidance to help you understand and effectively prepare, manage, and conclude with a successful EU MDR audit, this is the right session for you.