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EU Directives &
CE Marking Case Study
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This complimentary Webinar provides an overview of the three European Medical Device Directives and explains the process for obtaining a CE Mark. The presentation provides an overview of the associated guidance documents. The example of a low-profile, spinal pedicle screw is used as a case study example in this presentation. The case study explains how to determine the proper classification and to document the rationale for that classification. Milestones in the process for obtaining a CE Certificate are also explained.
Presentation topics include :
- Quality System Requirements
- New Approach EU Directives
- Technical Files & Design Dossier Requirements
- Guidance Documents
- Risk Classification of Devices
- Authorized Representatives
- Notified Body Selection
- Essential Requirements
- Declarations of Conformity
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presenter
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Rob Packard, Medical Device Academy, Inc.
The speaker has 20+ years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering with Quality Management System expertise covering all aspects of developing, training, implementing and maintaining compliance with ISO 13485 and ISO 14971. From 2009-2012, he was a lead auditor and instructor for a Notified Body. Rob’s specialty is regulatory submissions of high-risk medical devices for CE marking, Canadian medical device applications and 510(k) submissions. He founded the Medical Device Academy in 2012 as a consulting firm focused on helping medical device companies with regulatory submissions and quality system implementation. The most favorite part of his job is training others.
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Mick Howk, RAC, CQE, CQA SGS Regional Manager – Healthcare
Mick holds over twenty years’ experience in quality assurance and regulatory affairs. His experience includes over ten years working directly with European Notified Bodies assisting clients seeking global medical device approvals. He has successfully implemented and maintained ISO compliant quality systems resulting in certification. Mick has worked with companies seeking CE Marking under the MDD, IVDD and AIMD including startup companies as well as global corporations seeking to consolidate certifications. Mick has provided training to hundreds of employees on a broad spectrum of quality and regulatory topics. Mick holds a Master’s Degree in Management and a Bachelor’s Degree in Industrial Engineering Technology as well as numerous industry certifications in quality and regulatory.
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