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      5th Annual ComplianceOnline Medical Device Summit 2020 in Boston

      • 5th Annual ComplianceOnline Medical Device Summit 2020 Photo #1
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      April 16, 2020

      Thursday   8:00 AM - 4:35 PM (daily for 2 times)

      Boston, Massachusetts, United States
      Boston, Massachusetts

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      5th Annual ComplianceOnline Medical Device Summit 2020

      5th Annual Compliance Online Medical Device Summit 2020
      About this Event

      Key Attraction


      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.


      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.


      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.


      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.


      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.


      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.


      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 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:
      What is Critical to Quality

      Get Update on FDA compliance

      Listen from FBI:
      Cyber Security Risks

      Learn More about Medical Device Global Regulatory Landscape and Off-label Promotion
      Explore Upcoming Changes in Medical Devices under Trump Administration
      Change Management
      Criteria for Supplier Quality Agreement
      Establishing a Medical Device Security Program
      Panel Discussion
      FDA Warning Letter

      FDA Enforcement

      FDA Interaction

      Who Will Benefit?

      Quality Assurance/Quality Control
      Manufacturing and Contracting
      Supply Chain Management
      Sales, Marketing and Business Development
      IT and Software
      Risk Management and Product Lifecycle Management
      Executive Management
      Regulatory Affairs
      Research and Development
      Compliance Officers
      Consultants/Service Providers/Suppliers

      DAY 1 - APRIL 09, 2020

      8:00 - 8:30 AM

      Registrations and Networking Breakfast

      8:30 - 8:45 AM

      Welcome Speech with an Introduction of ComplianceOnline & Summit

      8:45 - 9:10 AM

      Current Healthcare Eco System: Challanges & Opportunities - Keynote

      9:15 - 9:45 AM

      Vendor Qualification and Selection - Panel Discussion

      9:45 - 10:35 AM

      Change Management and Change Control

      10:35 - 10:45 AM

      Networking Break

      10:45 - 11:20 AM

      Regulations in the U.S. and Globally (GDPR, Brexit, US-China Relationship)

      11:25 - 12:00 PM

      Medical Device Outsourcing, Supply Chains, Trade, Import/Export

      12:00 - 1:00 PM


      1:00 - 1:35 PM

      FDA Communication Power Tools - Panel Discussion

      1:40 - 2:30 PM

      Cybersecurity, Robotics, AI, Machine Learning, & Iot/IIoT

      2:30 - 2:45 PM

      Networking Break

      Track A - Sessions

      Track B - Sessions

      2:45 - 3:15 PM

      3D Printing

      MDR, IVDR

      3:25 - 3:50 PM

      Wearable Device


      4:00 - 4:40 PM

      Sterilization of Medical Devices - Workshop

      4:40 - 4:50 PM

      Closing Mark - Next Day Plan

      DAY 2 - APRIL 10, 2020

      8:00 - 8:30 AM

      Registration and Networking Breakfast

      8:30 - 9:00 AM

      Startups and $B Club - Keynote Speech

      9:05 - 9:35 AM

      REACH and RoHS and Enviormnetal Compliance in FDA Regulated Industries

      9:40 - 10:20 AM

      Medical Device Marketing and Advertisement, Social Media

      10:20 - 10:35 AM

      Networking Break

      10:35 - 11:10 AM

      Emerging Technologies of the Digital Health - Panel Discussion

      11:15 - 11:40 AM

      Medical Device TPLC (Total Product Life Cycle)

      11:45 - 12:15 PM

      21st Century CURES Act and ISO 62304:2016

      12:15 - 1:15 PM


      1:15 - 1:50 PM

      Quality Challanges and Risk Management (ISO 13485 and ISO 14971) - Panel Discussion

      Track A - Sessions

      Track B - Sessions

      1:50 - 2:20 PM

      FDA Compliance for SaaS/Cloud Environments

      Product Development: Engineering to Production

      2:20 - 2:50 PM

      Techincal Writing and Documentation

      Premarket, postmarket and Recall

      2:50 - 3:00 PM

      Networking Break

      3:00 - 3:30 PM

      Wearable Devices

      3:30 - 3:50 PM

      FDA Inspection and Meeting

      3:50 - 4:15 PM

      ISO 10993 and Biocompatibility - Workshop

      4:15 - 4:35 PM

      Vote of Thanks & Participation Certificate Distribution


      Lifei Liu, PhD, RAC

      Associate Director, Regulatory Affairs at Abbott

      Darin S. Oppenheimer, DRSc, RAC, FRAPS

      Executive Director, Head Drug Device Center of Excellence, Merck

      Matt Matuszewski

      Director Operations, Johnson and Johnson

      Peter Pitts

      Chief Regulatory Officer, Adherent Health, LLC.

      Kwame Ulmer

      Medical Device Executive | Angel Investor, Principal, Ulmer Ventures

      Tim Henning

      Co-Host of, HealthReform 2.0 Show and Podcast

      Thomas Loker

      Businessman | Author | Speaker, Startup Consultant and Advisor, SYDK.ORG

      Nick Sikorski,CISSP

      Manager, Deloitte & Touche LLP

      Robert Mai

      Senior Manager, Deloitte & Touche LLP

      Michael A Swit

      Principal, Law Offices of Michael A. Swit

      Catherine Casab

      MS Business Management, Quality Assurance Director, Third Pole Therapeutics

      Vesna Janic

      Director of Quality/Regulatory, StarFish Medical and ViVitro Labs Inc.

      Vee Arya

      Quality Director, Cannon Quality Group

      Mike Colvin

      Medical Device Consultant/Advisor, Syntilla Medical LLC

      Brian Shoemaker

      Principal Consultant, ShoeBar Associates

      Syed H. Askari PhD

      President, Medical Device Biopolymer LLC

      Virginia A. Lang, PhD

      President & Chief Scientist, HirLan, Inc.

      James Barley

      President, Ambired Consulting Services

      Darin S. Oppenheimer, DRSc, RAC, FRAPS

      Executive Director, Head Drug Device Center of Excellence, Merck

      Terri Jollymour

      (Sr. Director, Operations Readiness & Convergence

      Johnson & Johnson Corporate Supply Chain Quality & Compliance)

      Pat Baird

      Regulatory Head of Global Software Standards, Philips

      Tom Loker

      (Businessman | Author | Speaker, Startup Consultant and Advisor SYDK.ORG, Contributor to California Political Review)

      Dr. Ron Weissman

      (Chairman, Software SIG, Band of Angels)

      Stan Mastrangelo

      Technical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q9 Standards, Professor, Center for Applied Health Sciences, Virginia Tech University

      Daphne Walmer

      Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications

      Michael Weickert

      Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business

      Cost: $1,289 – $3,989

      Categories: Conferences & Tradeshows

      This event repeats daily for 2 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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