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5th Edition Conference

Annual Compliance Online Medical Device Summit

16 - 17 Apr 2020 Add To Calendar
Omni Parker House, Boston, USA

About Followers Reviews Exhibitors 3 Photos 7 Speakers Travel Deals

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.


Timings

8:00 AM - 5:00 PM (General)

Entry Fees

Paid Ticket Starts from 1199 USD View Details

Participants

200
Delegates

10 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma

Editions

16 - 17 Apr 2020 Interested


Frequency Annual

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ComplianceOnline USA

Top Rated 491 Total Events / 141 Upcoming Events

Schedule & Agenda

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Thu, 16 Apr 08:00 AM - 08:30 AM
Registration & Breakfast
Thu, 16 Apr 08:30 AM - 08:45 AM Opening Ceremony
Welcome Speech with an Introduction of ComplianceOnline & Summit
Thu, 16 Apr 08:45 AM - 09:10 AM Keynote
FDA Enforcement – Outlook & Implications

FDA Enforcement – Outlook & Implications

Thu, 16 Apr 09:15 AM - 09:45 AM Keynote
CDRH Office of Compliance Strategic Priorities and Hot Topics in Compliance
Thu, 16 Apr 09:45 AM - 10:15 AM Keynote
Current Healthcare Eco System: Challenges & Opportunities

Ensuring HIPAA security in today’s health IT environment requires HDOs hit a daily trifecta of HIPAA compliance, cyber security, and medical device management to ensure the IT infrastructure and PHI is protected. The FDA’s Guidance states there is a shared responsibility among health care facilities, health care providers, patients, and manufacturers. This collaboration of stakeholders demands a comprehensive security plan which must align key departments: (1) Cyber Security; (2) HIPAA Privacy and Security; and (3) HTM. Because IT departments understand the IT infrastructure, HIPAA privacy departments understand OCR rules and HTM understands the functionality of the device – repair and maintenance, there must be an understanding of whom manages specific threats to the IT network and the medical device.
Learn the strategies to develop thorough strategies to lessen and alleviate OCR violations should a breach occurs:

  • Incorporate functionality systems which detect cybersecurity events in devices, in a timely manner;
  • Develop strategies to contain medical device intrusion;
  • Contain the impact of a potential cybersecurity incident;
  • Create contracts which lessen the risk of the health delivery organization;
  • Learn strategies to ensure proper management of PHI captured within the medical devices.

Thu, 16 Apr 10:15 AM - 10:35 AM Session
Global Medical Device Regulations - US, EU, Canada, Brazil, China, Japan, Mexico, Russia, South Korea, Taiwan

This session will cover:

  • High level review of US GMP regulations and those significant GMP regulations worldwide regarding quality systems
    • US
    • Canada
    • Brazil
    • EU
    • China
    • Japan
  • Additionally, similarities between requirements will be covered.
  • Lastly, will cover where to expect GMP regulations to implement as we move forward into 2020.

Thu, 16 Apr 10:30 AM - 10:45 AM Break
Networking Break
Thu, 16 Apr 10:45 AM - 11:20 AM Session
GDPR 2020: The evolution of general data protection and the rights of individuals over their own data.

Nearly two years after becoming effective, the EU General Data Protection Regulation (GDPR) has had significant effects on companies around the world. This interactive session will have a panel of experts discussing the following key issues:

  1. A quick review of key GDPR principles and requirements
  2. How has GDPR affected the rest of the world and the U.S.?
  3. Where are we/you today nearly 2 years after GDPR went live?
  4. Is it too late to become compliant?
  5. Key steps to become GDPR compliant now.

Thu, 16 Apr 11:25 AM - 12:00 PM Keynote
Artificial Intelligence in Medical Device
Thu, 16 Apr 12:00 PM - 01:00 PM Lunch
Lunch
Thu, 16 Apr 01:00 PM - 01:35 PM Session
FDA Communication Power Tools

The US Food and Drug Administration offers a range of mechanisms to communicate with premarket review staff. The timing of communication and best practices to ensure both parties understand each other's messages is not well understood. Manufacturers regularly under-estimate the time and preparation required for effective communications for premarket applications and postmarket communications. Kwame Ulmer will highlight effective communication with FDA in a comprehensive manner to include the power tools that can be used immediately when seeking clearance, approval and effective compliance remediation.

Thu, 16 Apr 01:40 PM - 02:00 PM Session
Medical Device Outsourcing, Supply Chain Management and new Foreign Trade Problems for Import/ Export Business

Global markets create new and costly demands for a device import/export business. Firms must consider and update their short and long-term business plans to assure an effective positioning in the global market. New foreign regulatory requirements, effective quality assurance programs and evolving freight forwarding demands all require well planned in-house regulatory program to avoid expensive surprises and delays. For example, the European Union’s (EU) new Medical Device Regulation (MDR) and cybersecurity programs are hot topics for FDA that should be considered as the impact your products.

Thu, 16 Apr 02:00 PM - 02:30 PM Session
Vendor and Supplier Qualification and Selection.

Vendors and suppliers present new risks that require a systematic evaluation of their suitability for your product. You should establish and verify well defined qualification criteria to have proper management of the risks inherent in any 3rd party involvement. The FDA holds you responsible for what you accept from them and incorporate into your commercial service or product. Quality assurance functions present a core challenge to determine a domestic and foreign 3rd party’s willingness to meet your expectations. Your reliance cannot be based on blind faith. You and a third-party vendor or supplier need a dynamic relationship to avoid any manageable risk associated with your product. Key elements of a third-party quality assurance program and risk assessment practices will be identified.

Thu, 16 Apr 02:30 PM - 02:45 PM Break
Networking Break
Thu, 16 Apr 02:45 PM - 03:15 PM Session
3D Printed Medical Implants – Past, Future and… Present
#Track A - Sessions

The talk will provide audience with perspective on 3D printed medical implants & instruments current and future state. Care will be taken to highlight not only the 3D med device manufacturing evolution but also provide context on hype versus today’s reality. Talk will also highlight strategic business considerations in the 3D med device space.
The presenter will share perspective on key considerations required to successfully commercialize 3D printed medical devices. Content will also provide insights on appropriate product profiles as well as the critical role a clinical value proposition plays in driving market adoption.

Thu, 16 Apr 02:45 PM - 03:15 PM Session
MDR Implementation - Status, Next Steps and (revised) Timelines
#Track B - Sessions

  1. How to prepare for May 26, 2020 for devices using the soft transition
  2. Art 120(3)
  3. Economic Operators
  4. PMS/Vigilance
  5. Market Surveillance
  6. NB audits under MDR
  7. EUDAMED status update

Thu, 16 Apr 03:25 PM - 03:50 PM Session
Wearable Device
#Track A - Sessions
Thu, 16 Apr 03:25 PM - 03:50 PM Session
Software as a Medical Device - What to consider?
#Track B - Sessions

  1. Software as a medical device under MDR
  2. Apps as medical devices
  3. Software as part of a medical device
  4. Classification under MDR
  5. App Stores in regards of economic operators: status of the discussion

Thu, 16 Apr 04:00 PM - 04:40 PM Keynote
FDA Electronic Submission Process
Thu, 16 Apr 04:40 PM - 04:50 PM Closing Ceremony
Closing Mark - Next Day Plan

Visitor Ticket Price Buy Now

1199 USDVisitor/General Single Registration

Exhibitors List

3 Exhibitors of Current Edition
value.name

BSI

London, UK New Exhibitor
value.name

Toxikon

Bedford, USA New Exhibitor

ThinkMed

Denver, USA New Exhibitor
42.357587 -71.060205

Venue Map & Directions

map of Omni Parker House

Omni Parker House

60 School St, Boston, MA 02108
USA

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