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 the 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 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 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
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
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
2:45 - 3:50 PM
- Track A - Sessions: 3D Printing, Wearable Device
- Track B - Sessions: MDR, IVDR, EU MDD, MDSAP
4:00 - 4:40 PM
Sterilization of Medical Devices - Workshop
4:40 - 4:50 PM
Closing Mark - Next Day Plan
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
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
1:50 - 2:50 PM
- Track A - Sessions: FDA Compliance for SaaS/Cloud Environments, Technical Writing and Documentation
- Track B - Sessions: Product Development: Engineering to Production, Premarket, postmarket and Recall
2:50 - 3:00 PM
3:00 - 3:30 PM
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
- Nathan McBride - Vice president, Global IT and Orchard Therapeutics
- Oleg Norneinko - External Service and Operationa Quality Head, Novartis Institutes for BioMedical Research
- Charlie Schick - Business Development, Healthcare and Life Sciences, Owl Cyber Defence
- Archana Reddy - ExRegulatory Advisor/Public health Advocate (FDA)
- Jyotsna Mehta - Founder, Keva Health (Ex-FDA)
- Rob MacCuspie PhD - Industry Cosultant, Advisor and Scientific Director
- Barry Peterson - Independent Consultant, BTPeterson Consulting
- Tony RIzzo - Assistant VP Healthcare Development, BSI
- Zoe Braiterman - Consultant at GYMedical Device Consulting, LLC
- Kwame ULMer - Principal, Ulmer Ventures
- Casper E Uldriks - Former Associate Centre Director, FDA, CDRH
- Darin S. Oppenheimer - Executive Director, Regulatory Devices and Digital Health Solutions, Merck
- Ben Lockwin - Healthcare Futurist, SVP of Quality at Lumicell and International Speaker
- 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
Omni Parker House Hotel
60 School Street
Directions from Hotel
The hotel is 2.5 miles from Logan International Airport. It normally takes 15-20 minutes to get to the hotel depending on traffic.
Taxi from Logan Airport: Fare average is between $20 and $28 depending on the traffic.
Taxi to Logan Airport: Fare average is between $20 and $25 depending on the traffic.
All rates are subject to change.
Public Transportation: Eco-friendly travelers can take advantage of Boston’s MBTA train service located only one block from the hotel. From Logan Airport, take the Blue Line to State Street station, which is only a three-minute walk to the hotel. Fare is $2.65 each way. Bus #22 stops at Terminals A and B and the Airport subway station. Bus #33 stops at Terminals C and E and the Airport subway station. Take the Logan Airport Terminal A shuttle bus towards the loop. Take the Bus Walk 1 minute to the Airport Station and take the MBTA Blue Line to State Street.
- See more at: http://www.omnihotels.com/hotels/boston-parker-house/property-details/directions#sthash.o3El7Mqk.dpuf
Please Note: If you are traveling with a GPS, you must enter the 02108 ZIP code into your GPS device or you will be directed to another School Street in the Boston area. A second option is to request directions toward 45 Province Street, which is located directly next to us.
FROM POINTS NORTH VIA 95 SOUTH
Take 95 South to Exit 46 and onto Route 1 South. Stay on Route 1 South and proceed over the Tobin Bridge (toll) into Boston. Take the left ramp onto Route 93 South, then Exit 24 for Government Center. Turn left onto John Fitzgerald Surface Road, then turn right onto State Street. Proceed straight; the road name will change to Court Street. Bear left onto Tremont Street, then turn left onto School Street. Omni Parker House is immediately on your right.
FROM POINTS SOUTH VIA 95 NORTH
Take 95 North to Exit 12 and merge onto Route 93. Proceed on Route 93 into Boston and take Exit 24 for Government Center. Turn left onto John Fitzgerald Surface Road, then turn right onto State Street. Proceed straight; the road name will change to Court Street. Bear left onto Tremont Street, then turn left onto School Street. Omni Parker House is immediately on your right.
FROM POINTS NORTH VIA 93 SOUTH
Follow the signs for 93 South to Boston-Quincy. Take Exit 24A Government Center. Proceed straight onto Clinton Street to the first set of lights. At the lights, take a left onto North Street. Follow North Street to the end and take a left onto Congress Street. Follow Congress to the first set of lights and bear right onto State Street (which becomes Court Street almost immediately). Follow Court Street 1 block and bear left at the fork onto Tremont Street. Follow Tremont Street to the next set of lights and bear left onto School Street. The hotel will be on your right-hand side.
FROM POINTS SOUTH VIA 93 NORTH
Take Exit 23 Government Center/Faneuil Hall. At the top of the ramp, follow the signs for Government Center/Faneuil Hall. This will put you onto North Street. At the end of North Street (.25 miles), make a left onto Congress Street. Take your first right onto State Street (which becomes Court Street almost immediately) and follow it to the end, making a left at the fork onto Tremont Street. Take your first left onto School Street and Omni Parker House is immediately on the right.
FROM THE MASS PIKE (ROUTE 90)
Follow Mass Pike going Eastbound to Exit 24 B. This exit will put you on Route 93 going North. Follow the directions directly above for taking 93 North to get to Omni Parker House.
FROM LOGAN INTERNATIONAL AIRPORT
Exit the airport and follow the signs for the Ted Williams Tunnel. Take Exit 24 for 93 North. Follow 93 North to Exit 23 Government Center. At the set of traffic lights, make a left around the loop, which will put you onto North Street. At the end of North Street (.25 miles), make a left onto Congress Street. Take your first right onto State Street (which becomes Court Street almost immediately) and follow it to the end, making a left at the fork onto Tremont Street. Take your first left onto School Street and Omni Parker House is immediately on the right. You may also utilize Boston's MBTA train service.
Boston is well-served by ground transportation companies that run throughout the city.
The hotel concierge can arrange car rental, limousine or town car service.
From the Amtrak South Station, the cab ride to the hotel is $7.
MBTA train service is located a block from the hotel.
MBTA Park Street Station (Red or Green line) is a four-minute walk
MBTA State Street Station (Blue or Orange Line) is a two-minute walk
MBTA Downtown Crossing Station (Red or Orange Line) is a four minute walk