2-day In-person Seminar

Global Medical Device Regulation


August 31st & September 1st, 2016

Time: 8:30 AM to 5:30 PM

Boston, MA

Venue: Embassy Suites Boston at Logan Airport


Director : Thomas E. Colonna
  Price: $1,495.00
(Seminar Fee for One Delegate)

Download Registration form

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

Course "Global Medical Device Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements, the course provides the student with resources to meet the regulatory requirements for the largest world markets. Country-specific regulatory requirements for Canada, EU, and US are included.


Why should you attend:

This course provides a basic description of global regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful global strategies for medical devices, including definitions and classifications worldwide, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product approval pathways.


Areas Covered in the Session:

  • Describe the elements impacting the definition and classification of medical devices globally
  • Determine the points to consider in the development of a global regulatory strategy
  • Define the tools for global regulatory strategy development
  • Recognize sources of regulatory and competitive intelligence
  • Identify the elements of a regulatory plan
  • Apply global regulatory principles to develop a regulatory plan

Who Will Benefit:

  • Regulatory professionals working in the medical device field

Day 1 Schedule


8.30 am - 9.00 am

Registration & Breakfast


Lecture 1: 9 am - 10.30 am

Overview of FDA Medical Device Regulation


10.30 � 11.00 am

Tea break


Lecture 2: 11.00 am - 12.30

Overview of FDA Device Manufacturing Issues


12.30 pm - 1.30 pm

Lunch break


Lecture 3: 1.30 pm - 3.00 pm

Overview of FDA Device Post-Market Surveillance


3.00 pm - 3.30

Tea Break


Lecture 4: 3.30 pm - 5.00 pm

Overview of Global Supply Chain Issues


Lecture 5: 5.00 pm � 5.30 pm

Q & A

Day 2 Schedule


8.30 am - 9.00 am

Registration & Breakfast


Lecture 1: 9 am - 10.30 am

Overview of EU Medical Device Regulation


10.30 � 11.00 am

Tea break


Lecture 2: 11.00 am - 12.30

Overview of Canada Medical Device Regulation


12.30 pm - 1.30 pm

Lunch break


Lecture 3: 1.30 pm - 3.00 pm

Overview of EU and Canada Post-Market Surveillance


3.00 pm - 3.30

Tea Break


Lecture 4: 3.30 pm - 5.00 pm

Overview of Device Regulatory Strategies


Lecture 5: 5.00 pm � 5.30 pm

Q & A

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Suite 216, Fremont, CA 94539, USA
Phone: 1800 447 9407

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

Thomas E. Colonna

Founder, Biotech Consultant LLC

Dr. Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.

Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products. Dr. Colonna�s consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.

Location: Boston, MA Hotel: Embassy Suites Boston at Logan Airport   207 Porter St. Boston, MA 02128

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