Conference and Workshop FAQs

How is the 5th Annual Medical Device Regulations Conference different from other conferences?

The 5th Annual Medical Device Regulations Conference is unique because it is jointly sponsored by the University of Georgia College of Pharmacy and the US Food and Drug Administration.

The conference provides a concentrated, cost effective way to learn about the latest news and priorities that impact all medical device companies directly from both FDA and international regulators.

FDA management participated in the conference’s design, and their engagement by both speaking and attending means attendees get real-time information directly from FDA.

 

What are the conference topics this year, and why do they matter to participants?

This year’s conference will provide attendees with a tremendous amount of important information in only one day. The topics have been chosen to help attendees keep up with critical current events in the medical device regulatory world and gain valuable knowledge from experienced industry leaders.

From regulators, attendees will hear about what to expect with FDA’s Office of Regulatory Affairs alignment, FDA’s perspective regarding expectations of contract manufacturer controls, how to prepare for the new EU Medical Device Regulations (EU MDR), and changes to MEDDEV 2.7.1 Revision 4 – Clinical Evaluation Report (CER) Requirements.  Each of these topics are important for medical device professionals to keep up with and be aware of.

Industry speakers will share their knowledge and experiences regarding defending device claims–FDA & FTC, best practices for compliance with ISO 13485:2016, and the importance of Quality and Regulatory throughout the merger and acquisition life cycle.

Given the large amount of timely, important information provide over one day the conference clearly represents a strong value for all attendees.

 

What is the workshop topic this year, and why does it matter to participants?

This year’s workshop topic is: “Implementing the Medical Device Single Audit Program (MDSAP) with ISO 13485: 2016 Considerations”

The Medical Device Single Audit Program (MDSAP) is an international initiative led by five Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.

Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW) ran a three year pilot program that ended in December 2016 and the formal program began in January 2017. Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates. If MDSAP certificates are not provided to Health Canada by January 1, 2019 for existing Canadian Licenses of class II, III, and IV medical devices, they will be voided and the associated devices will no longer be permitted to be marketed/sold in Canada.

BSI’s MDSAP Expert will provide training to help prepare your organization for an MDSAP compliant QMS while also providing comparisons to ISO 13485:2016.  Industry experts that have already undergone MDSAP audits will also provide implementation strategies and watch-outs they have learned.

At the completion of this workshop you will have a general working knowledge of:

  1. What is the MDSAP Program
  2. How MDSAP works
  3. How does MDSAP fit with other certifications?
  4. MDSAP financial impacts
  5. MDSAP audit duration impacts
  6. MDSAP grading scale
  7. Understanding the requirements of the MDSAP Audit Model
  8. Using the MDSAP Companion Document as your guide to compliance
  9. Comparisons to ISO 13485:2016
  10. Implementation strategies/watch-outs

 

Where is the 2017 conference located, and is lodging available?

This year the conference is in suburban Atlanta at the UGA Gwinnett Campus, which is conveniently located in the northeast suburbs off Old Peachtree Road and I-85, making it convenient for both Atlanta-based attendees and attendees who will fly into Atlanta’s Hartsfield Jackson Airport.

Attendees will receive a discounted rate at the nearby Homewood Suites by Hilton Atlanta I-85-Lawrenceville-Duluth, which is adjacent to the Sugarloaf Mills Mall, a 1,200,000-square-foot shopping mall with over 180 specialty retailers.