Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society




2021 RMRAS Quality System Regulation PLUS
Friday, September 24, 2021
8:00 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 ISO 13485:2016 standard.

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.

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


John Mann, Director, Evergreen Research
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.


Malissa Sailakham, Senior Quality Assurance Specialist, Corgenix
Quality Management System professional with 20 solid years of experience in Medical Device and IVD.  Specializes in QMS compliance, development, implementation, and evaluation of systems to ensure products and operations meet corporate objectives, integrity, and efficiency standards established by the organization and regulatory requirements.  Institutes continuous process improvement focused not only on product and service quality, but also on the means to achieve it.



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 additional registrants' fee will be $350.00 per person. Contact Nan Matthews,, for more details and a link to the discounted price. 


Masks and social distancing will be required at the Corgenix facility.
Please note below the recent letter from the RMRAS President, Daniel Simpson, about two documents which must be read and accepted before you can register. 

"At the start of the COVID-19 pandemic, the RMRAS board made the decision to carry on with regular meeting presentations using a remote webinar format in order to comply with CDC guidelines and local health regulations.  Now that regulations and guidelines have loosened, we are finally preparing to begin in person presentations again, beginning with our annual Quality System Regulation Course scheduled for September.  In order to be able to provide in person meetings, we have needed to institute the below policies for our membership related to the COVID-19 pandemic.

  • COVID-19 Liability Waiver- You will have to accept this waiver upon web registration for RMRAS events.   This protects RMRAS against any legal action related to COVID-19 infection and exposure.
  • Code of Conduct- Attendees will have to agree to abide by these rules at the time of registration.  The Code of Conduct will mirror any locally enforced protocols issued by the state or county.
  •  Refund Policy- The refund policy has been updated to allow for full refunds in the case of members experiencing COVID-19 symptoms on the day of the event as well as members that may have been recently exposed to COVID-19."

If the state and/or county limits in-person gatherings, RMRAS may need to move the QSR Plus course to a virtual format.  We will inform all registrants of such a decision as soon as possible.  There will be no refund if this change is initiated due to COVID restrictions. 

Corgenix Inc.

11575 Main Street, Ste 400

Broomfield, CO 80020

To register, please go to:

For additional details or information, contact Nan Matthews, or 303-843-6414.


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Rocky Mountain Regulatory Affairs Society


Phone: +1 (303) .843-6414


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