Shifting from the Medical Device Directive to the new EU-MDR expectations won’t be simple. But having a fully integrated quality management system, updating your labeling and packaging requirements and implementing technical file solutions can make the process more effective and efficient.
This Medical Device Package and Labeling Compliance Under EU-MDR webinar on Nov. 20 will help you get the answers you need. With expert insights, you’ll gain a better understanding of artwork and labeling compliance and determine how to best move forward.
Bob Tilling, Business Development Manager at Kallik, and Simon Hoffman, Principal Quality Assurance and Regulatory Affairs Consultant, will share tips on meeting the key labeling requirements for the new EU-MDR. They’ll talk about ways companies have managed the transition and implemented systemic solutions for moving forward.
- Key labeling and overall requirements for the EU-MDR
- Action plans to update artwork and labels for IVDD devices by May 2022 and class IIa and IIb devices by May 2023
- How other medical device companies have risen to the challenge of compliance by using technology to proof artwork and label regulation changes
- The transition between the MDD and the MDR
- Full, systemic solutions that integrate with a quality management system and company operations
- Ongoing regulatory, industry and customer requirements
- The best way to achieve full compliance without detriment to customer and patient delivery, avoiding the traditional reactive compliance approach
Get the knowledge you need to ensure packing compliance by registering for this webinar.
Who Will Benefit
- Device development teams
- Quality specialists
- Regulatory affairs specialists
- Compliance specialists
- QSR professionals
- Inspections and audit professionals
- Post-market safety teams
- Submissions and approvals staff
- Research and development professionals
- Commercial operations teams