5th Annual Medical Device Summit 2020 (Boston, MA, United States – April 16-17, 2020) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “5th Annual Medical Device Summit 2020” conference has been added to ResearchAndMarkets.com’s offering.

Key Attraction

Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations.

Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.

Build FDA compliant quality management systems. Attend this summit to learn how to develop and implement effective, consistent and reliable quality management systems. Ex-FDA officials and senior company executives will share thoughts and ideas to improve the performance of your current system.

Interact with leading minds in the industry. Attendees will get to network with the prominent decision-makers in the industry to exchange ideas, offer thoughts and know-how, and share experiences. Joining this summit will offer a unique opportunity to the attendees to market their offerings and identify new business opportunities.

Deliberate the current state of medical device laws and technology and government oversight. Panel comprising of some of leading medical device experts and veterans will discuss the recent changes to the regulatory environment for the medical device industry and how these changes will impact the approval of new devices. Attendees will gain insight into the current issues and future challenges in the industry. Join this summit to hear from the experts who have extensive experience in all aspects of medical device including R&D, manufacturing quality assurance, approval and commercialization process.

Scale factors for successful medical device commercialization. Discussions with industry veterans through real case studies will help medical researchers, healthcare professionals, industrialists and entrepreneurs’ better understand the criteria’s for successful commercialization of medical devices. This summit also offers numerous opportunities for medical device companies and suppliers to showcase their products and services to potential customers, generating leads and growing their businesses.

Enhance risk management strategies for the safe, effective and efficient use of medical devices. Medical device professionals will join together to share their knowledge and best practices for implementing good risk management principles within the industry. Attending this summit will help you to develop a robust and integrated risk management plan to improve the quality management system.

Why you should attend this summit

  • Future Trends of Medical Device Regulation, Risk Management, UDI, Recall Complaint Management etc.
  • Listen from FDA/CDRH Directors:
  • Listen from FBI:
  • Learn More about Medical Device Global Regulatory Landscape and Off-label Promotion
  • Explore Upcoming Changes in Medical Devices under the Trump Administration
  • Change Management
  • Criteria for Supplier Quality Agreement
  • Establishing a Medical Device Security Program
  • Panel Discussion

Agenda:

Day 01

8:00 – 8:30 AM – Registrations and Breakfast

8:30 – 8:45 AM – Welcome Speech with an Introduction of ComplianceOnline & Summit

8:45 – 9:10 AM – FDA Enforcement – Outlook & Implications – Keynote

FDA Invited (ORA)

9:15 – 9:45 AM – CDRH Office of Compliance Strategic Priorities and Hot Topics in Compliance – Keynote

FDA Invited (CDRH)

9:45 – 10:15 AM – Current Healthcare Eco-System: Challenges & Opportunities – Keynote

Coy Murchison, Chief Strategy Officer, Berry Herring Hayes & Associates

10:15 – 10:35 AM – Global Medical Device Regulations – US, EU, Canada, Brazil, China, Japan, Mexico, Russia, South Korea, Taiwan

John Riggi, President and CEO, Lake Ontario MED DEV Consultants

10:35 – 10:45 AM – Networking Break

10:45 – 11:20 AM – GDPR 2020: The evolution of general data protection and the rights of individuals over their own data.

L. Stephan Vincze, President & CEO, Trestle Compliance, LLC (Former Counsel, U. S. House of Representatives Committee)

11:25 – 12:00 PM – Artificial Intelligence in Medical Device – Keynote

FDA Invited (CDRH)

12:00 – 1:00 PM – Lunch

1:00 – 1:35 PM – FDA Communication Power Tools

Kwame Ulmer, Principal, Ulmer Ventures (Ex-FDA)

1:40 – 2:00 PM – Medical Device Outsourcing, Supply Chain Management and new Foreign Trade Problems for Import/ Export Business

Casper E. Uldriks, Former Associate, Center Director of FDA’s CDRH

2:00 – 2:30 PM – Vendor and Supplier Qualification and Selection.

Casper E. Uldriks, Former Associate, Center Director of FDA’s CDRH

2:30 – 2:45 PM – Networking Break

Track A – Sessions

2:45 – 3:15 PM – 3D Printing

3:25 – 3:50 PM – Wearable Device

Track B – Sessions

2:45 – 3:15 PM – MDR Implementation – Status, Next Steps and (revised) Timelines

Bill Enos, Senior Commercial Operations Director, Regulatory Services (Medical Devices) Americas, BSI Group

3:25 – 3:50 PM – Software as a Medical Device – What to consider?

Royth v. Hahn, Global head of TUV SUD’s Business Unit, Medical and Health Services (MHS)

Day 02

8:00 – 8:30 AM – Registration and Breakfast

8:30 – 9:00 AM – NanoEHS Risk Assessment Lessons for Medical Devices – Keynote Speech

9:05 – 9:35 AM – Protecting Company Revenues with Product Compliance – Keynote

Kelly Eisenhardt, Managing Director & Co-Founder, BlueCircle Advisors

9:40 – 10:00 AM – Medical Device Advertising and Promotion: Compliant Marketing Communication Practices in the Age of Social Media

Howard L. Dorfman, Esq., Adjunct Professor, Seton Hall University School of Law

10:00 – 10:20 AM – Exploring what is new in the FDA’s approaches to premarket, post-market and Recalls in the medical devices area

Haja Sittana El Mubarak, PhD, Former FDA Official, Senior IVD consultant, Biologics Consulting Inc

10:20 – 10:35 AM – Networking Break

10:35 – 11:10 AM – Emerging Technologies of the Digital Health – Panel Discussion

Jyotsna Mehta, Founder, Keva Health (Ex-FDA)

11:15 – 11:40 AM – Medical Device Enhancements – Keynote

FDA Invited (CDRH)

11:45 – 12:15 PM – Cybersecurity, Machine Learning and IoT/IIoT

Zoe Braiterman, Consultant, GYMedical Device Consulting, LLC

12:15 – 1:15 PM – Lunch

1:15 – 1:50 PM – Quality Challenges and Risk Management (ISO 13485 and ISO 14971) – Panel Discussion

Track A – Sessions

1:50 – 2:20 PM – Combination Products

Archana Reddy, Ex-Regulatory Advisor/Public, Health Advocate, (FDA)

2:20 – 2:50 PM – Technical Writing and Documentation

Track B – Sessions

1:50 – 2:20 PM – Cyber Security

Charlie Schick, Business Development, Healthcare and Life Sciences, Owl Cyber Defense

2:20 – 2:50 PM – CHANGE CONTROL – Is Your Change Management System Effective?

Stephanie Harrell, CQA (Former US FDA Investigator) Quality and Compliance Consultant, Auditor and Trainer, ProPharma Group

2:50 – 3:00 PM – Networking Break

3:00 – 3:30 PM – Robotics and Artificial Intelligence (AI)

Nathan McBride, Vice President, Global IT, Orchard Therapeutics

3:30 – 3:50 PM – FDA Inspection – Keynote

FDA Invited (ORA)

3:50 – 4:15 PM – ISO 10993 and Biocompatibility – Workshop

Oleg Kornienko, External Service & Operations Quality Head, Novartis Institutes for BioMedical Research (NIBR)

4:15 – 4:35 PM – Vote of Thanks & Participation Certificate Distribution

Speakers

Casper E Uldriks

Former Associate Center Director, FDA, CDRH

Coy Murchison

Chief Strategy Officer, Berry Herring Hayes & Associates

L. Stephan Vincze

President & CEO at Trestle Compliance, LLC

Kwame Ulmer

Principal at Ulmer Ventures

Zoe Braiterman

Consultant at GYMedical Device Consulting, LLC

Bill Enos

Senior Commercial Operations Director at BSI Group

Royth v. Hahn

Global head of TUV SUD’s Business Unit at Medical and Health Services

Kelly Eisenhardt

Managing Director & Co-Founder, BlueCircle Advisors LLC

Howard L. Dorfman

Adjunct Professor, Seton Hall University School of Law

Haja Sittana El Mubarak

Senior IVD consultant, Biologics Consulting Inc

Jyotsna Mehta

Founder, Keva Health (Ex-FDA)

Archana Reddy

Ex-Regulatory Advisor/Public, Health Advocate, (FDA)

Charlie Schick

Business Development, Healthcare and Life Sciences, Owl Cyber Defense

Stephanie Harrell

Former US FDA Investigator at ProPharma Group

Nathan McBride

Vice President, Global IT at Orchard Therapeutics

Oleg Kornienko

External Service & Operations Quality Head, Novartis Institutes for BioMedical Research (NIBR)

John Riggi

President and CEO, Lake Ontario MED DEV Consultants

For more information about this conference visit https://www.researchandmarkets.com/r/yb5x5n

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