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CER/PER Best Practices For EU MDR and IVDR Compliance
February 4, 2020 @ 9:00 pm - February 5, 2020 @ 12:00 pm
You are invited to an Evening Meeting
Networking and Educational Opportunity
CER/PER Best Practices
Clinical Evaluation and Performance Evaluation Reports
Preparing for EU MDR and IVDR Compliance and Notified Body Audits
February 5, 2020
5:00 – 8:00 pm
Join In Person or On Webinar
Eventbrite Online Registration: https://www.eventbrite.com/e/cerper-best-practices-for-eu-mdr-and-ivdr-compliance-tickets-88594028123
3 Hours Towards Your RAPS RAC Recertification
Location:
Applied Medical – 30200 Avenida de las Banderas, Building R105, Rancho Santa Margarita, CA 92688
Host:
Anna Feng, Regulatory Affairs, Applied Medical
Program Managers and Moderators:
Karen Greene, CPP, Vice President Client Solutions, Network Partners Professional Services
Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant
Presenters and Panelists:
Garbiele Howard, Manager, Systems Certification, Region North America
Maria Nyåkern, PhD, President CEO/Principal Advisor AKRN Scientific Consulting SL, Madrid
Angela Siebeneck, RN, MSN, Director of Medical Writing, Network Partners
Schedule of Presentations:
5:00 – 5:30 pm Check-In, Networking, and Refreshments
5:30 – 6:15 pm Clinical Evaluation Reports—EU MDR Compliance and Comprehensive Tutorial
Speaker – Angela Siebeneck, RN, MSN, Director of Medical Writing, Network Partners
6:15 – 7:00 pm Performance Evaluation Reports—IVDR Compliance and Comprehensive Tutorial
Speaker – Maria Nyåkern, PhD, President CEO/Principal Advisor AKRN Scientific Consulting SL, Madrid
7:00 – 7:30 pm How Notified Bodies Will Audit CERs and PERs
Speaker – Gabriele Howard, Nemko, Manager, Systems Certification, Region North America
7:30 – 8:00 pm Panel Discussion and Closing Remarks
Synopsis:
CER’s – Compliance to MEDDEV 2.7/1 REV. 4 and the EU MDR 2017/745: Regulatory requirements from the MEDDEV 2.7/1 revision 4 and the EU MDR 2017/745 have increased the challenge of writing Clinical Evaluation Reports (CERs).
Great emphasis is placed on the scientific aspects of the clinical evaluation, the competence and independence of the “evaluators” (section 6.4 and Appendix A11), and the need to make this a living document that must be updated regularly or whenever there is a safety or clinical performance issue. Our CER speaker, Angela Siebeneck, RN, MSN and medical device professional, will provide expert insight from her industry experience working with all elements of CER writing. Angela will address “What is State of the Art and why is it important?”
State of the Art (SOTA) was mentioned four times in MEDDEV 2.7/1 Rev 3, thirty-nine times in MEDDEV 2.7/1 Rev 4 and nine times in the MDR. With the increased scrutiny on Clinical Evaluation Reports additional emphasis has been placed on establishing SOTA. It is important to establish the landscape and ground to support the relevance of the device as a treatment option for the condition treated and establishing the safety and performance. The requirements for searching and constructing the SOTA, as well as specific examples will be reviewed.
PER’s – The Performance Evaluation Report (PER), described in Article 56 of the IVDR, includes three elements: scientific validity, analytical performance, and clinical performance. Our PER speaker, Maria Nyåkern, PhD, will guide us through the compliance requirements and provide her insights on the generation of “sufficient clinical evidence” in a cost-effective manner.
Cost:
OCRA Members: $60 in-person attendance or $40 webinar* attendance
Non-Members: $135 in-person attendance or $115 webinar* attendance (includes OCRA Membership fee)
Government and Students in-person attendance: $35 for members or $70 for non-members (includes OCRA Membership fee)
Government and Students webinar attendance: $20 for members or $55 for non-members (includes OCRA Membership fee)
FREE for Applied Medical Employees (please register for the Free ticket option on Eventbrite)
If you have any questions or require additional information, email OCRA Program Chair (ocraprogramchair@gmail.com).
Registration deadline is February 4th. No same day (in-person or webinar) or on-site registrations will be allowed. You must register for this event using Eventbrite: https://www.eventbrite.com/e/cerper-best-practices-for-eu-mdr-and-ivdr-compliance-tickets-88594028123
No multiple ticket purchases please. Please purchase one ticket at a time and use the attendee’s name in order for that person to be listed on the security check-in list and for that person to receive program materials.
*Webinar attendees: Email ocraprogramchair@gmail.com by February 3rd for a link to the webinar.
Speaker and Panelist Bios
Garbiele Howard, Manager, Systems Certification, Region North America
System Certification Manager at Nemko, USA. Responsible for the Certification Business and International Client Management to facilitate Market Access for various Clients. Results-oriented Leader with extensive experience in Strategic Management, Business Development, Training of Employees and Budget Planning. Focus on Organizations and their regulatory Competencies. Strong background in Leadership and Training. Client-focused Regulatory Affairs Professional with over 25 years at Certification bodies and over 20 years of helping clients with certification needs and CE-marking. On-site Audits include but are not limited to medical devices that are regulated under FDA, EU and Health Canada regulations. Experience with a wide variety of regulations including ISO9000, ISO13485, and a variety of European Directives including the Medical Devices Directive. Areas of expertise include Quality Management Systems, Risk Management, EU Technical File Reviews and Leadership Development. Creative Professional always driven to succeed.
Maria Nyåkern, PhD, President CEO/Principal Advisor AKRN Scientific Consulting SL, Madrid
Maria Nyåkern is the President and CEO of AKRN Scientific Consulting and responsible for the day-to-day business as well as leading the organization to align the company to enable innovation and expansion in the medical device B2B sector. Ms. Nyåkern is a Clinical and Regulatory Expert and founded AKRN Scientific Consulting in 2015 after working nearly 15 years in the regulatory and clinical development of medical device technology and commercialization of healthcare products. Maria Nyåkern is a Doctor of Cell Biology at the Stockholm University, Sweden (2003) and has completed a Postdoctoral Fellowship at the University of Bologna, Italy (2006). Maria is fluent in English, Spanish, Italian, French and Swedish.
Angela Siebeneck, RN, MSN, Director of Medical Writing, Network Partners
Angela brings twenty-five years of clinical expertise as a Registered Nurse specializing in interventional radiology, surgical intensive care, trauma, dialysis, vascular access and wound care. Angela is the Director of Medical Writing for Network Partners where she leads the medical writing team with her expertise in medical devices, clinical data, and clinical writing. She has extensive experience in European clinical requirements for EU MED DEV 2.7/1 Rev 4 and MDR. She has reviewed and authored over 100 Clinical Evaluation Plans and Reports for all device classes to meet regulatory and clinical requirements.
OCRA Registration Instructions
In-person registration fee includes light snacks, beverages, free parking and access to electronic presentations after the meeting (if approved by speaker for distribution).
To register for this event, go to: https://www.eventbrite.com/e/cerper-best-practices-for-eu-mdr-and-ivdr-compliance-tickets-88594028123
Registration deadline is February 4th. No same day (in-person or webinar) or on-site registrations will be allowed. You must register for this event using Eventbrite.
No multiple ticket purchases please. Please purchase one ticket at a time and use the attendee’s name in order for that person to be listed on the security check-in list.
*Webinar attendees: Email ocraprogramchair@gmail.com by February 3rd for a link to the webinar.
OCRA’s non-profit Federal Tax ID# 33-0630455
Cancellation Deadline:
For a refund, please email your cancellation request to OCRA Program Chair (ocraprogramchair@gmail.com) by January 29, 2020.
If you have any questions or require additional information, email OCRA Program Chair (ocraprogramchair@gmail.com).
