2022

We are pleased to announce an encore presentation of our QSR PLUS Course

2022 RMRAS Quality System Regulation PLUS
Friday, April 1, 2022
8:30 am - 5:00 pm

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

 
The Quality System Regulation PLUS Course is designed to provide students with a basic understanding of the requirements of the QSR regulation and the implications of the FDA proposed Rule on the Quality System. Regulation.

WHO SHOULD ATTEND?
This course is directed towards those who work within the design, implementation and maintenance of a quality system, and work in QA, R&D, manufacturing, and/or regulatory affairs. This is an introductory course offering a high-level overview of the regulatory requirements of QSR and the expectations of the ISO 13485:2016 standard.

COMMENTS FROM THE 2021 QSR ATTENDEES

“Great level of experience across all the speakers.  I really appreciated the examples and real-life stories.  This always provides chances to learn new things through the speakers’ years of experience. “

“Very good in translating into understandable language for novices like me!  I’m very impressed.”

“I would recommend or suggest that the rep FDA rep is very good to have in this class going forward!  His info was great. I liked being able to ask questions and listen to others that were put to him.”

SPEAKERS

RMRAS is pleased to have two experienced industry professionals as our instructors this year.

John Mann, Director, Manager, Engineer, ERI Group
Mr. Mann has established himself as a leader in the overall integration and execution of regulatory affairs & quality system planning and execution into the medical device design, development, and manufacturing continuum.  During his over 25 years in the medical device field, he has successfully implemented regulatory approvals for medical devices in both the US, EU and other global markets.  He has successfully mitigated and remediated recall and market withdrawal situations for large and small companies, and he has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU and global market requirements.

Daniel Simpson, RAC (US, CAN), ASQ CBA. - Senior Director, Clinical and Regulatory Affairs, Corgenix

Mr. Simpson is currently the Senior Director of Clinical and Regulatory Affairs at Corgenix Inc. which produces In Vitro Diagnostic (IVD) products for the clinical laboratory market as a part of the Sebia Group of companies.  Mr. Simpson currently is in charge of all clinical and regulatory activity for the company’s current product portfolio.  Additionally, Corgenix offers contract development, clinical, regulatory, and commercialization activities for companies that have research diagnostic products for which they are seeking regulatory authorization as an IVD.   In this capacity, Mr. Simpson has developed regulatory and clinical strategies for submissions, market authorization, and registrations worldwide.  

REGISTRATION FEE

Class size is limited to 20.  This is a most popular annual event, so sign up as soon as possible.

The fee for the course is $395.00 which includes morning refreshments, a box lunch, course material and electronic presentations.

If a company wants to register more than three attendees, the fourth and any additional registrants' fee will be $350.00 per person. Contact Nan Matthews, programs@rmras.org, for more details and a link to the discounted price. 

VENUE COVID REQUIREMENTS (from Registration form)

Below is a preview of statements from the Registration form.  You will need to make the appropriate responses to them before you can complete the registration process.

I have been vaccinated and will send my proof of vaccination to RMRAS at least one week prior to the class to Nan Matthews, programs@rmras.org.  I understand I do NOT have to wear a mask in the class or venue by meeting this requirement.

I have not been vaccinated or will not send proof of vaccination and understand that I will need to wear a mask while at the venue for the QSR class.

If I am sick with COVID symptoms or recently tested positive, I will inform RMRAS and will NOT attend the class. I understand that my registration fee will be fully refunded.

LOCATION:
Corgenix, Inc.

11575 Main Street

Broomfield, CO  8002

To register, please go to:  https://cvent.me/eOvY8P\

For additional details or information, contact Nan Matthews, programs@rmras.org or 303-843-6414.

Topic Ideas?

Please send us your ideas for meeting topics, programs, classes, etc. Email info@rmras.org.