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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The EU MDR (EU 2017/745) date of application, 26 May 2021, is quickly approaching, meaning expanded
requirements for clinical evaluations. This webcast will provide an examination
of the clinical evidence for unique product types and therapeutic areas, including combination products,
software as a medical device (SaMD), and legacy devices. We will also discuss the new
draft guidelines and requirements along with our teams approach for creating
the necessary templates for these products. Following the presentation there will be a Q&A Panel for questions
from the audience. This event will include a collection of individuals from the
field. A representative from a Notified Body, subject matter expert, regulatory
consultant, and others, will be partaking in our presentation and discussion
panel to provide a comprehensive perspective on the challenges and solutions in
preparing Clinical Evaluations.
Who Should Attend:
Pratibha Mishra, Associate Manager of Medical Device Services, Celegence
Dr. Pratibha Mishra is an associate manager, Medical Device
Services for Celegence where she leads a team of qualified medical writers. She has a
Master’s degree in Oral Medicine and Maxillofacial Radiology and has written
and reviewed regulatory documentation for medical devices covering a wide range
of therapeutic areas – dentistry, ophthalmology, thoracopulmonology,
gastroenterology, endoscopy, urology and dialysis, general surgery,
electrosurgery, female reproductive health, cosmetic surgery, diagnostic and interventional
radiology, and cardiology. Her team has successfully conducted clinical
evaluations for complex devices including software as a medical device (SaMD) and drug-device combination products. She is experienced in developing MDR
compliant templates for CER, CEP, PMCF
Plan, and PMCF Report, and drafting responses to notified body observations on
Dr. Matthias Fink,
Clinical Focus Team Manager - North America, TUV SUD
Dr. Matthias Fink is board-certified orthopedic and trauma
surgeon with over 17 years of experience in orthopedic, trauma and
reconstructive surgery and extensive training in cardiovascular and thoracic
surgery. He has expert knowledge in the field of orthopedic implants and
cardiac devices. Dr. Fink has also worked as a Clinical Reviewer for the
Clinical Centre of Excellence for TÜV SÜD Product Service in Germany before
joining TÜV SÜD America in 2017. He is
the Global Team Leader for the Ortho, Trauma and Dentistry Team within the
Clinical Centre of Excellence of TÜV SÜD and the Team Manager of the Clinical
Focus Team in North America. He has been a presenter at national and
international conferences on the clinical requirements and the implementation of
the EU MDR. Dr. Fink is also an external trainer on clinical and post-market
aspects under the MDR for TÜV SÜD America. During his clinical career he has
been an investigator and co-investigator in national and international clinical
studies for medical devices and Phase III and IV clinical trials for
Medical Device Regulatory Consultant, Celegence
Sharma Pokkuluri is an accomplished, analytical, and highly
organized QMS auditor and regulatory affairs management professional with over
8 years of frontline experience successfully overseeing the drug pipeline and
legal compliance of a leading CRO and ensuring stringent quality standards
across diverse pharmaceutical research and market analysis.
John Bradsher, Medical Device Regulatory Expert, Celegence
John Bradsher is an RAC holder and subject-matter expert on regulatory affairs and quality assurance of medical devices for Celegence. He
has a background in the EU MDR that is both broad and deep; he has managed the
program for MDR compliance at a medium-sized manufacturer of vascular medical
devices and managed the development of clinical
evaluation documents for a global manufacturer, BauschHealth. His strong science and biotechnology background combined with his
mastery of regulatory offers him a unique and knowledgeable perspective. He
has cleared several 510(k)s and has worked on products in EU classes I-III in
his 27 years of project management.
Audience Learning Level: Advanced
This webcast content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.