Meet our Qserve team at the RAPS Regulatory Convergence 2018

October 01, 2018 - October 04, 2018 / Canada

Date: October 1 - 4, 2018

Location: Vancouver, British Columbia, Canada

RAPS Regulatory Convergence is an annual multi-day gathering of the global regulatory community. It brings together the profession's best and brightest leaders from government, industry, academia, research and other key disciplines to address global, regulatory and business challenges and share strategies for success. 

Meet our team in person at the RAPS Convergence, held from 1 to 4 October 2018. You can find Qserve in the exposition area, Booth 414. 

With offices in the USA, Europe, and China we are an essential partner for medical device manufacturers. With our global team of multilingual consultants, Qserve's expertise and experience provide international support, on a local level. 

Meet the following Qserve Group US staff:

Dr. Gert Bos, Executive Director & Partner;  
Dr. Keith  Morel, VP of Regulatory Compliance; 
Mindy McCann, VP of Regulatory Compliance;
Lorry Huffman, Principal Consultant and IVD expert;
Jennifer Hadfield, Manager of Qserve Group’s east coast office. 

Session topics:

  • US Regulatory Essentials, Medical Devices and IVDs (Speaker: Lorry Huffman)
  • Global Impact & Implementation on the EU MDR & IVDR (Speaker: Gert Bos)
  • Statistical Methods for the RA Professional (Speaker: Keith Morel)
  • Technical Documentation for Compliance (Speaker: Mindy McCann) 

 

Oct 1:

9:00 AM

- 5:00 PM

US Regulatory Essentials, Medical Devices and IVDs

A comprehensive overview of US regulatory affairs for devices and IVDs, this workshop will benefit individuals who are new to the regulatory profession, changing product line or industry or preparing for the RAC (US) examination.

Lorry Huffman, MT (ASCP), CLS

Oct 1:

11:00 AM

Conformity Assessment in the MDR

  • Routes to CE marking and conformity assessment with MDR
  • GAP analysis between ISO 13485:2016 and the MDR QMS requirements

Gert Bos, PhD, FRAPS, Executive Director & Partner, Qserve Group

Oct 1:

1:30 PM

Technical Documentation for Compliance

  • MDR Annex II technical documentation requirements
  • Notified Body evaluation of technical documentation

Mindy McCann, VP Regulatory Compliance, Qserve Group.

 

Oct 2:

10:45 AM

PMS/PMCF

According to article 83 of the medical device regulation, the post-market surveillance system shall be suited to actively and systematically gathering, recording and analyzing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions. Further on in this regulation, it is mentioned that PMCF is a continuous process to update the clinical evaluation and is part of the PMS plan. During this workshop, we would like to explain to the attendees based on examples of the way to comply with the new regulation by using various methodologies.

Keith Morel, PhD, US VP Regulatory Compliance, Qserve Group

 

Oct 3:

10:30 AM

-12:00 PM

Broad Stakeholder Panel Debate on Global Impact and Implementation of the EU Medical Device Regulations MDR and IVDR

In this session, the panel will address the most crucial topics that are hindering rapid implementation and will look to provide as much clarity on these critical items as currently possible. It will help you understand how to solve the unsolvable, will instruct you and your implementation teams how to move on and what to aim for. In this panel discussion, the panel will tackle the key obstacles current on your way to implement the EU legislation and will get you back on your way for a timely demonstration of your compliance to the new rules.

Gert Bos, PhD, FRAPS, Executive Director & Partner, Qserve Group

 

 

 

Oct 4:

8:30-9:30 AM

Statistical Methods for the RA Professional

Focusing on the three examples given, Keith shares his experiences and knowledge, to give the participants a starting point from which to make suitable judgments of the techniques used within Qserve.

Keith Morel, PhD, US VP Regulatory Compliance, Qserve Group

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Visit RAPS website for specific workshop details.

 

Profiles:

Gert W. Bos
Jennifer Hadfield
Keith Morel
Lorry Weaver Huffman
Mindy McCann
Post date: May 28, 2018
Tags
Subscribe to the Qserve Newsletter and follow us on LinkedIn
Want more information? Get in touch with us
Information request