- MDD 93/42/EEC-Articles 1-23
- 10 steps to obtaining a CE Mark (i.e., device classification, conformity assessment procedure, choose notified body, etc..)
- “Special Notified Bodies,” implementing the QMS
- technical documentation
- design dossier defined
- technical file vs. design dossier-3 critical differences
- essential requirements
- authorized representative defined
- types of CE certificates
- declaration of conformity
- product registration
- affixing the CE mark
- post market design changes
- maintaining your technical file
- and more.
A medical device manufacturer must meet MDD requirements in order to legally place a medical device on the European market. This 50+ minute webinar, presented by subject matter expert, Rob Packard of Medical Device Academy, explains a number of critical requirements and provides detail to illustrate important concepts.
This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
Includes Native PowerPoint Slides – Webinar recording will be delivered in a separate email (Due to large file size)
Exam and Training Certificate available for $49.00:
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Please also view our Webinar on Preparing European CE Marking Requirements: How to Convert Class IIb Technical File Class III Design Dossier – Click Here
VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:
About Your Instructor
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.