Medical Device Package and Labeling
Compliance Under EU-MDR


This webinar has been cancelled.

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.

Webinar Takeaways:

  • 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

 

Meet Your Presenters

Bob Tilling

Business Development Manager
Kallik

Bob Tilling has more than 20 years of experience in enterprise artwork and labeling projects within the medical device and pharmaceutical industries. He has successfully completed projects involving changes to all forms of labels and artwork to meet EU-MDR compliance requirements. Tilling has recently worked with medical device companies on managing both a lack of resources combined and the unexpected scale of regulatory changes. He has developed systems and solutions to answer these compliance needs.

Simon Hoffman

Principal Quality Assurance and Regulatory Affairs Consultant

Simon Hoffman has more than 26 years in the fully regulated medical device and pharmaceutical industries. He began his career in labeling and packaging services and has a proven track record of implementing full quality management systems. He has supported full manufacturing facilities and successfully hosted more than 80 FDA, MHRA, MDSAP and ISO inspections and audits. He has also led the launch of extensive medical device products of all classifications to global markets.

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