This EU Regulation webinar series consists of eight one-hour webinars designed for medical device manufacturers that are CE Marking medical devices.
This webinar is designed to provide training for medical device manufacturers that are CE Marking or intend to CE Mark products. The training is specific to the new Regulation (EU) 2017/745. Trainings will be conducted live each week on Thursdays at Noon EST. However, each session will be recorded and you will receive access to download the recording for training of current and future employees.
How to demonstrate effectiveness of EU Regulation Webinar Series
We are providing short quizzes to verify that training was effective for each webinar. The webinar series costs only $825/company, and this includes quizzes and training certificates for one person. If you want quizzes and training certificates for additional people, this can be purchased at any time at a price of $49/quiz or $312 for all 8 quizzes. This webinars will also be available as individual purchases for $129/each.
EU Regulation Webinar Series Content
- January 24, 2019 – Overview of Changes: Introduction, Transition Dates, Economic Operators, Expert Groups, Recertification of NBs, Validity of Certificates, and Transfers for Authorized Representatives and NBs (Annex XII)
- January 31, 2019 – Classification & Reclassifications: How to prepare a classification rationale; Annex VIII – Classification Rules; Annex XVI, Devices without a medical purpose
- February 7, 2019 – Conformity Assessments: Annex IX, X and XI; Notification of Significant Changes; Post-Certification Scrutiny; Annex XIII – Procedures for Custom-made Devices
- February 14, 2019 – Annex I: Essential Requirements & Labeling Requirements, UDI implementation
- October 19, 2018 – Creating a Risk Management File compliant with new MDR
- February 21, 2019 – Technical Documentation: Annex II
- February 28, 2019 – PMS and Clinical Data: Annex III, Annex XIV, Annex XV, Clinical Investigations, Clinical Evaluations, PMCF, and Post-Market Surveillance
- March 7, 2019 – Areas with Significant Changes: Annex IV – EU Declaration of Conformity, Vigilance Reporting, Record Retention, Single-Use Devices & Reprocessing, Annex VI – UDI and other information submitted to economic operators
What you will receive:
- Invitation to participate in 7 live training webinars (Thursdays @ Noon EST, starting January 24, 2019)…One training recorded October 19, 2018
- Recording of 8 webinars
- 8 Native PowerPoint Slide Decks
- 8 Quizzes for Training Effectiveness
- 8 Training Certificates for Successful Completion
- 30-minute, private discussion via Zoom to discuss your MDR quality plan or any matters related to Regulation (EU) 2017/745
Webinar Series is $825.00 (Includes 8 webinars, native slide decks, 8 quizzes and certificates for training effectiveness):
This EU Regulation webinar series consists of eight one-hour webinars designed for medical device manufacturers that are CE Marking medical devices. The training series begins on January 24, 2019.
Please note: These products will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
About Your Instructor
Rob Packard is a regulatory consultant with 25+ 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. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.