Best Practices on MDR Transition Under Current Conditions (On-Demand)

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As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR

This is an On-demand recording from December 2021.

This event is brought to you by Qualio

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 post market 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

Image: https://my.raps.org/images/3bd0f53f-74c1-461d-bccf-26fefe2eb40c.img

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.