Medical Device Summit 2015

1. March 19-20, 2015, San Diego, CA
ComplianceOnline is a leading provider of regulatory compliance trainings for
companies and professionals in regulated industries. ComplianceOnline has
successfully trained over 35,000 professionals from 9,000 companies to comply with
the requirements of regulatory agencies.
ComplianceOnline has a strong, proven track record in conducting live, in-person
seminars and workshops to train professionals from industries such as life sciences,
health care, banking and financial services, manufacturing, software and more.
Building on this decade-long expertise, ComplianceOnline is conducting its first
Medical Device Summit this year in San Diego, CA.
summit - 2015

2. The medical device industry continues to
experience rapid growth rates. This success has
brought along with it a number of challenges
relating to quality, regulatory compliance,
technology, innovation, taxation, supply chain
management and more.
The ComplianceOnline Medical Device Summit
will provide a venue for industry experts,
professionals and executives to discuss and debate
these challenges as well as explore new strategies
and opportunities for growth. The event will also
be an exclusive business opportunity for medical
device companies – stalls will be available for
organizations to exhibit their latest products and
technological innovations. From a marketing and
branding perspective, the event provides
unrivalled and once-in-a-lifetime opportunity for
both established as well as up-and-coming
medical device companies and their suppliers.
The new Medical Device tax that is continuing
to prove controversial in the US and beyond
The increasing threats to patient safety and
company reputations because of cyber-attacks
The rapid changes in technology that can make
even a smartphone a medical device and the
legal/safety issues these bring
Recent product safety related lawsuits – how
will these influence the future direction of the
industry?
Supply chain management and third party
reliability remain major challenges for the
industry
The Event





An Industry Facing Major
Challenges
Issues that the Medical Device industry is
facing at present include:
2
summit - 2015

3. The ComplianceOnline Medical Device Summit will be one of the largest gatherings of medical device
companies, suppliers, professionals and experts in 2015.
This event gives professionals – whether they are new entrants in the field or middle management or veterans – to
interact with the leading minds in the industry about the current state of laws and technology and government
oversight and more. Professionals will get CPE credits after attending workshops and also get prime networking
opportunities with their industry peers from the across the US.
The discussions, debates, workshops and exhibitions will also throw light on the direction the industry will take in
the future – making it all the more important for today’s medical device professionals to actively take part in the
ComplianceOnline Medical Device Summit.
Why Attend This Event?
Post-Event Online Community
Exclusively only for the conference
attendees
A platform to discuss the latest and most
pressing issues affecting the global
medical device industry
A networking tool provided to all attendees
of this conference for continuous
networking opportunity.
Delegates will benefit from:
Focused multiple track workshops
Prime networking opportunities with your peers
from companies across USA
One-Stop-shop, inviting A-Z suppliers for
Med-Dev industry
Pre-Course Questionnaire to understand
individual’s needs
CPE credits on workshops
Post-Event Online Community access to stay in
touch with all other attendees
3
summit - 2015

4. Delegate package includes
1. Complete access to presentations, panel discussions, keynote sessions for 2 days
2. Full access to selected workshops
3. CPE credits (for approved workshops) and attendance certificate at the end of the program
4. Access to course materials
5. Access to networking luncheons and coffee breaks on both the days
6. Complimentary access to Post-Event Online Community
7. Discounts on seminars/webinars and other products worth $630.
Delegate Registration Details
$699No. Of Participants - 2
$599No. Of Participants - 3 & 3+
$799No. Of Participants - 1
*Above prices are for per attendee
4
summit - 2015

5. 2.40PM - 3.00PM 20 Mins Sponsor Speaking Opportunity2.40PM - 3.00PM 20 Mins Sponsor Speaking Opportunity
Agenda
Day One: Thursday, March 19, 2015
8.00AM - 9.00AM
9.10AM - 9.40AM
60 Mins Registration
9.00AM - 9.10AM 10 Mins Introduction - Welcome Speech with an introduction of ComplianceOnline & Summit
30 Mins
Inspirational Keynote - Growth & Opportunities 2020: Vision 2020 & Beyond
• Aging Population and threat to society
• Increase of direct pressure on MD industry as a sudden rise of healthcare services need
• MD for better life style
• Analyst Presentation - Political Changes
• Market volatility because of political changes
• Is Obamacare leading MD to Loss?
9.40AM - 10:30AM 50 Mins
Panel Discussion - Role & Market Evolution of USA
• World leader in MD Manufacturing (58% of Market Share)
• Top & Raising Global MD Markets for business: BRIC, EU, Japan, Korea, Latin America, Australia
10.30AM - 11.00AM 30 Mins
11.00AM - 11.20AM 20 Mins Networking Coffee/Tea Break
12:40PM - 2:00 PM 80 Mins LUNCH
11.20AM - 12.00PM 40 Mins Sponsors Speaking Opportunity
12.00PM - 12.40PM 40 Mins
Venture Investing -
Finding capital today is difficult no matter what the stage of the company. This panel of entrepreneurs and
CEOs will share their experiences in the search for capital.
• Understanding Corporate Investors and Buyers
• Changing Areas of Investor Interest investment
• Managing Your Patent Portfolio
5
2.00PM - 2.40PM 40 Mins 2.00PM - 2.40PM 40 Mins
Track A - Sessions Track B - Sessions
**Track A is most suitable for Top Level executives from various
depts. However attendees of all levels can attend it.
**Track B is more suitable for Mid-Level Managers from
Compliance, Regulatory, Quality, Project Mgmt & R&D depts.
However attendees of all levels can attend it.
Mergers & Acquisitions
The M &A environment, for the medical device industry is constantly
changing. This round table discussion will bring together executives
and notable experience in the medical device industry and beyond.
The roundtable discussion will also focus on Meetings with
Stakeholders to identify opportunities and recommendations, Factors
which influence the value of M&A.
They Panelist have had numerous successes and consequent
failures: working with investors, selling and buying companies, and
starting all over again. They will be sharing their deep insights on
their Experiences, Following will be covered:
• How were their companies started and sold?
• What lessons were learned the hard way?
• What would they have done differently?
• Advice for the future?
Medical Device Recall and Compliant Management
Medical Device Reporting (MDR) and recall compliance are critical
to the continue survival of all device manufacturers. The FDA is
continuing their efforts to issue numerous FDA Warning Letters
and serious enforcement actions, including criminal & civil
penalties levied on companies that failed to properly report events
and take proper corrective and removal actions. The number of
device companies having their recall classified as a Class 1 (most
severe) recall has surged in the past three years. Additionally,
product liability and financial risks are staggering when companies
fail to properly report and take action when required.
This workshop will cover:
• FDA Expectations: Complaint System Inspections
• Medical Device Reporting (MDR)
• Workshop: Complaints vs. MDRs...is it or isn't it reportable?!
• Corrective & Preventive Action System (CAPA)
• FDA's Medical Device Recall Process
• How Industry Should Handle Recalls
[Cont...]
The 21st century FDA - Help or hindrance to innovation
Many blame the FDA for being a sea anchor to medical innovation? But is that simply urban mythology? With
new regulatory pathways for expedited approval as well as new industry and academic collaborations, the
FDA is more involved with accelerating innovation than ever before. What is the agency doing and why is it so
misunderstood? This presentation will offer insights into the agency's actions and philosophy relative to
innovation as well as why it is being negatively perceived by many of its key constituencies."
summit - 2015

6. 4.40PM - 5.20PM 40 Mins
Be FDA Inspection Ready
How to prepare for the inspection, how to prepare your subject
matter experts (SME’s) to respond properly, and how to respond to
an FDA 483 or Warning Letter. Case Studies and Templates are
included. – Featuring Ex FDA’s
• Discussing inspectional protocols – how should you treat
investigators when they are in your facility
• A day in the life of an investigator -- how inspectors prepare and
approach assigned inspections
• New for 2014 – Understanding FDA’s Quality Metrics Initiative –
what’s the latest on the quality initiative and how can you get
prepared for what’s coming?
• New for 2014 – The latest on the FDA’s re-organization of the
inspectional corps and how could it impact your daily operations
and your upcoming inspection
• Best practices in FDA 483 and warning letter management and
recovery
4.00PM - 4.40PM 40 Mins
3.40PM - 4.00PM 20 Mins Networking Coffee Break
5.20PM - 5.30PM 10 Mins Closure: Summary
3.00PM - 3.40PM 40 Mins3.00PM - 3.40PM 40 Mins
4.00PM - 4.40PM 40 Mins
Track A - Sessions Track B - Sessions
Agenda
GLOBALIZATION: THE CHALLENGES AND SOLUTIONS
The Med Device industry is experiencing a significant
transformation. Attest 50% of med Devices used in US are
imported. The Globalization of design, sourcing, manufacturing,
distribution and sales of Med device has Created Challenges and
Opportunities for the entire Med Device industry. The medical
device manufacturing and research and development (R&D) sectors
are extremely complex.
The growth in the Volume of global Partners, Facilities, Suppliers,
and regulations and as well as the increased variety and complexity
of Products access a large number of countries has its employees
on alert. They are Specially Concerned about
• Making and adapting products for different markets
• Greater complexity in supply chains
• Complying with increasingly Complex regulatory Environment
• Raw Material Requirement – Quality Assurance across the Globe
• Protecting your medical device Intellectual Property
The Evolution of Portable Medical Devices
According to Gartner, portable consumer medical devices, such as
blood glucose monitors, blood pressure monitors, insulin pumps
and heart rate monitors, represent the fastest-growing segment in
the medical equipment market. A recent medical semiconductor
report by Databeans also projects that the home medical device
segment will grow by 9 percent (combined annual growth rate or
CAGR) over the next five years. With the advent of various smart
technology and wireless capabilities, this medical field has become
one of the most intriguing with the promise of great potential for
future healthcare.
The Round Table Discussion will emphasize on:
• what risks must be addressed in the management of power
sources for portable medical devices in the critical care
environment.
• User interface: display
• Human machine interface (HMI): keypads, scroll wheels, buttons,
and switches
• Bio-sensor(s)
• Amplification and analog-to-digital conversion of the sensor input
4.40PM - 5.20PM 40 Mins
Debate - Debate - “Yes” or a “No” to Outsourcing
This Will address some of the key benefits, challenges, and trends
in outsourcing medical device design and development and how
they can impact your business
• Govt. Policies on MD Outsourcing
• Coming to Terms with Outsourcing
• what, when, and how much to outsource
• How to select the right partner for your company's needs
GMP Compliance for Quality Control and Contract Laboratories
Quality control and related contract laboratories are considered at
high risk because after testing and approval, drug products and
Active Pharmaceutical Ingredients (APIs) are released to the market
without further check. That's the reason why the FDA and other
agencies put highest emphasis on inspections of QC laboratories.
Even though cGMP regulations have been in place since long time,
the large number of QC related 483's and warning letters
demonstrate that companies have problems with implementation
• FDA Regulations and Requirements Overview
• Calibration and Qualification of Laboratory Equipment
• Sample Testing: Preparation, conduct, documentation
• Handling out of specification (OOS) test results
• Quality assurance of reference standards and other supplies
• Ensuring Integrity of Raw Data and Other records
• Internal audits in preparation for FDA inspection
Significant change in the risk management landscape
After many years of trying to create a consistent worldwide
approach to medical device risk management, success seemed to
be in our grasp with the publication of ISO 14971:2007. Almost
every country harmonized that standard with little or no change.
Unfortunately, the harmonization process in the European Union
created deviations to the standard that must me met as part of the
essential requirements, and ISO 14971 by itself no longer meets
their risk management requirements. This schism with the rest of
the world is causing consternation among medical device
manufacturers that market globally. This talk will provide some
history, some discussion of harmonization, some philosophy, and
some potential solutions to minimizing the impact of the EU
deviations.
3.40PM - 4.00PM 20 Mins Networking Coffee Break
6
summit - 2015

7. Agenda
Day Two: Friday, March 20, 2014
8.00AM - 8.30AM
8:30AM - 9.10AM
30 Mins Registration/Sponsored Breakfast
40 Mins
Keynote - FDA's New Import Program Concerning International Consequences
• Selecting foreign suppliers
• Reducing the risk of detention
• Negotiating with FDA and U.S. Customs
• Special Provisions
10.00AM - 10.40AM 40 Mins
9.10AM - 10.00AM 50 Mins
Panel Discussion - Advanced Technology - An Essential Resource
• Utilizing new technologies for devices industry
• Analyzing present and prospective
• Demonstrating the benefits of the real time
• An in-depth look at industry from the viewpoints of nanotechnology, Big Data, and Robotic & Artifical
Technologies and vertulization
• Mobile apps: Navigating new Regulatory Guidance on Mobile Medical Apps. FDA stipulations of mHealth
market in the near future. Understanding mHealth parameters.
• MD on cloud: Cloud computing involves the delivery of computing as a service rather than a product.
Cloud computing presents several challenges to FDA’s application of its existing regulatory scheme.
• Big Data: refers to data sets of enormous scope.
• Nano Technology: NanoScience is the study of phenomena and manipulation of materials at atomic,
molecular and macromolecular scale. Nanotechnology is the design, characterisation and application of
structures, devices and systems by controlling shape and size at the nanometer scale.
11.30AM - 12.00PM 30 Mins
10.40AM - 11.00AM 20 Mins Networking Coffee/Tea Break
11.00AM - 11.30AM 30 Mins Sponsors Speaking Opportunity - 2 sponsor
12.00PM - 12.40PM 40 Mins
Keynote - Human Factors & Medical Device
• FDA Perspectives on Human Factors: Conduct a comprehensive risk assessment. Identify and mitigate
risk. Discuss product development plans with FDA before your design is finalized.
• Human Factors & Usability: FDA believes that medical device use error impacts the health and well-beings
of the public and hence its looks closely to HF/Usability. HF/Usability evaluations, test method, and results.
Disapproval can result from inadequate HF/ Usability.
• FDA/CDRH Pre-market Review Perspective: Evaluating use-related risks analyses, and human
factor/usibility information and validation study data including submissions. They would also provide
recommendations to the multi-disciplinary review team on human factors evaluation of manufacturers' design
validation documents as required by the Quality System Regulation. The recommendations are reviewed and
incorporated in FDA letters to the device manufactures.
• Human Factors Preliminary Analyses: Identify and analyse intended users and expected used scenarios
and use environment. Develop Initial product concepts and prototypes. Identify and explore potential device
use-hazards and risk their potential clinical consequences. Explore different design alternatives and identify
the trade-offs between them.
• Formative Evaluation and Design Modification: Formative evaluations are conducted to inform product
development in progress. Guide modification of the device design to optimize the user interface with respect
to device safety and effectiveness.
• Human Factors Validation Testing: Demonstrates and provide evidance that a Medical device can be used
safely and effectively. Identify expected use conditions. Assessments of device-user interactions.
• HF/Usability Report: Discuss user performance after use, particulary perceived reasons for any essential
and critical task errors, failures and difficulties. Feedback on design of the device, labeling and training.
Measuring speed of the task completion if its clinically meaningful.
12.40PM - 2.00PM 80 Mins Networking Lunch
7[Cont...]
The Growing Labeling Concern for Device Manufacturers and Users
Customers and regulatory bodies are requiring device manufacturers to provide more comprehensive
Instructions for Use for all devices, regardless of device class. This session will highlight what problems
customers experience with IFUs, what information customers are looking for from manufacturers, steps
manufacturers need to take to provide comprehensive IFUS, and resources available to help manufacturers
meet this increasingly critical labeling requirement.
• ISO 17664
• AAMI TIR12
• AAMI TIR30
• FDA Draft Guidance on Processing/Reprocessing Medical Devices in Health Care Settings
Future Trends in Medical Device Risk Management."
Risk Analyses have been required to CE Mark medical devices since the 1980's. Risk Management has
been required since 2000, yet there continues to be controversy over Best Practices. This presentation will
summarize where we have been to determine what we should be doing. Future scenarios will be discussed
with recommendations.
Some of the key areas of Discussion will have the below
• Background Highlights
• Current Controversies
• Best Practices
• Future Recommendations
summit - 2015

8. 2.00PM - 3.00PM 60 Mins
Track A - Sessions Track B - Sessions
**Track A is most suitable for Top Level executives from various
depts. However attendees of all levels can attend it.
**Track B is more suitable for Mid-Level Managers from
Compliance, Regulatory, Quality, Project Mgmt & R&D depts.
However attendees of all levels can attend it.
Agenda
4.00PM to 4.20PM 20 Mins Networking Coffee Break
4.20PM to 5.00PM 40 Mins Prize, Sponsor Prize & Certificate Distribution, Summary & Closure
8
CMO -Are You choosing them Right?
It's time for medical device and life science instrument OEMs to
take another look at outsourcing the entire manufacturing process
from New Product Introduction through final system test. For years,
other industries have embraced outsourcing as the manufacturing
strategy of choice. While the cost benefits of outsourcing are well
documented, the solutions offered by most outsourcing companies
fall short of what medical device and life science instrument OEMs
require. This Workshop will emphasize on the Key Criteria for
Selecting the Right CMO for you . Below Areas will be Covered.
• CMO Inspection Trends with CMOs
• Assessing CMOs’ Financial Stability
• Assuring Quality from CMOs
Sunshine Act : How ready are we?
• Analyze the New Regulations Released in the Sunshine Act and
How the Requirements Effect Aggregate Spend Reporting
• Reporting 101: Addressing the Issue of Who, What, Where, When
and How to Report Aggregate Spend
• Challenges Occurred in First Period
• Impact on Business due to Additional Exposure
Supply Chain Optimization - Enhancing Controls & Controlling
Risk
Supply chain issues remain major concerns for both FDA and
industry. Supplier problems lie at the root of a significant
percentage of quality risk events and field actions. This session will
provide update on evolving regulatory expectations and concerns,
• Trends and current Agency concerns
• Overview of recent enforcement actions
• Risk considerations
• The six pillars of supplier quality
• Applying critical-to-quality concepts to supplier selection and
management
• Industry best in class practices
• Inspecting quality in vs. root cause investigation and QSR
• Special considerations for early stage suppliers
• Collaborating with vendors on product development
• Outgrowing early suppliers as products or companies mature
• FDA stance on supplier certification
UDI Granular Interpretation & Road Ahead
This session will provide an overview of the high-level interpretation
of the UDI Regulation and will help you gain insight into what has
happened within the FDA leading up to, and after the first major
compliance date for Medical Device Manufacturers. You will be
provided with a glimpse into the forthcoming milestones and
anticipations for the industry in regards to UDI implementation.
• In House System Requirement for UDI Compliance
• Getting started with Global UDI Database
• Understanding the Device Indetifier
• Global Medical Device Nomenclature (GMDN) and GUIDD
• GUDID Submission Options
• The Global Landscape: UDI & Hospital-Related Efforts Around
the World
2.00PM - 3.00PM 60 Mins
3.00PM - 4.00PM 60 Mins3.00PM - 4.00PM 60 Mins
summit - 2015

9. Why San Diego?
March 19-20, 2015
San Diego, CA
CONTACT US
2600 E. Bayshore Road
Palo Alto, CA 94303
Toll Free number: +1-650-284-1695
Email: summit@complianceonline.com
San Diego is a major hub for scientific research and development. The city is an important center for medical
device innovation – leading companies such as NuVasive, Care Fusion, Medipacs and SpectraScience are
headquartered here while companies such as Boston Scientific, Stryker and DePuy are located in nearby San Jose.
The spirit of entrepreneurship not in just San Diego but the whole of Southern California has made it the ideal
environment for start-ups.
As one of California’s legendary coastal cities, visitors come to San Diego to enjoy its wonderful climate, natural
attractions and rich history. Some of the city’s most popular destinations include:
The strong culture of technological innovation, ground-breaking scientific discovery and spectacular urban and
natural heritage makes San Diego the ideal venue for an important industry event like the ComplianceOnline
Medical Device Summit.
The San Diego Zoo is one of the world’s most famous zoological treasures, with a huge botanical plant and
orchid garden as well.
The San Diego Air and Space Museum preserves the rich past of the aviation industry as well as space
technology. It aims to encourage study in science, engineering and technology.
La Jolla Shores is one of the must-see and must-experience destinations for scuba divers, snorkelers and
kayaks. Nature lovers also go to La Jolla to experience the underwater park – around 6,000 acres of tide lands
and artificial reefs with an abundance of marine life.



9
summit - 2015
summit - 2015