Sponsored Webcast: Best Practices on MDR Transition Under Current Conditions

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RAC Credits
Virtual Programs
Wednesday, 15 December 2021 (11:00 AM) - Wednesday, 15 December 2021 (12:00 PM) Eastern Time (US & Canada)
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Since the EU MDR May 2021 date of application went into effect, medical device manufacturers have been trying to apply the MDR’s new compliance requirements to new and existing devices. The ultimate decision on how well these compliance actions have been satisfied resides with the manufacturer’s chosen notified body (NB). As one of the leading NB’s in these transition cases, BSI will share a series of “lessons learned” in a webinar on December 15, 2021 from actual case reports of manufacturers moving through the transition process, including:
  • Technical documentation errors such as typical missing information and poor structure (which can impede the review process)
  • Legacy device compliance challenges such as historical testing applicability, data organization for meeting new MDR requirements, device changes and company acquisition issues
  • Harmonization/application of existing standards such as ISO 14971 device risk management and ISO 13485
  • How well devices are meeting General Safety and Performance Requirements (GSPRs) of MDR 2017/745)
  • Post Market Surveillance and Vigilance under MDR
  • Commercial and Eudamed experience and future timelines
The program’s featured speaker will bring a unique perspective based on her diverse experience and perspectives with medical device regulation in quality management systems, technical documentation, device classification, and post market responsibilities.

Learning Objectives

  • Avoid technical documentation errors which can impede the review process, such as typical missing information and poor structure
  • Surmount legacy device compliance challenges such as historical testing applicability, data organization for meeting new MDR requirements, device changes and company acquisition issues
  • Harmonize the application of existing standards such as ISO 14971 device risk management and ISO 13485
  • Determine how well their devices meet the General Safety and Performance Requirements (GSPRs) of MDR 2017/745)
  • Comply with the postmarket surveillance and vigilance requirements of EU MDR

Who should attend?

• Regulatory personnel with responsibility for attaining/maintaining international medical device certifications and regulatory compliance
• Those who have direct or indirect responsibility for auditing the medical device quality management system such as internal and lead auditors
• Those who must collect, analyze and apply medical device regulatory intelligence
• Medical device manufacturer staff who decide, manage and maintain their company’s relationship with their chosen Notified Body (NB)
• Those engaged in medical device clinical and developmental research and medical device design
• Any who have titles relating to Regulatory Information, Regulatory Counsel, Compliance, Pre/Post-Regulatory approval, Product Life Cycle or Device Marketing

Speakers


Keti Agostino
Regulatory Lead
BSI The Netherlands Notified Body
Keti holds a Bachelor degree from the University of Massachusetts and has over 13 years of experience gained in both industry and BSI. During her industry career, she provided technical direction and managed international submissions and global regulatory strategies for various implantable medical devices. In her current role, Keti is a Regulatory Lead for BSI The Netherlands Notified Body and is responsible for regulatory oversight for medical devices, including strategy, policy, procedures and documentation to ensure compliance with the various legislative and designation requirements.


Event Policies

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

Registration fees are nonrefundable. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

 

Contact Us

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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