Biomedical Consortium Current Events

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Quality Systems for EU MDR and MDSAP

EU MDR, CER’s, Brexit, UDI, MDSAP, GDPR… so many acronyms and the
underlying topics influencing medical device regulatory strategy and quality
compliance in the next several years.

*   Where do we begin?
*   Who should be responsible for the various aspects? Who should be my
person responsible for regulatory compliance (is this the same as the
management representative?)?
*   How do we make sure we are incorporating these regulatory requirements
within established quality management system?
*   Why enroll in the MDSAP program? What is the alignment with ISO
*   Are the requirements for UDI in the EU the same as they are for the

These are just a few of the questions that will be addressed by Mark
Swanson, President of H&M Consulting Group, LLC and Lena Cordie, President
at Qualitas Professional Services, LLC. as they discuss the quality and
regulatory strategies for tackling the two topics with the greatest combined
impact on our current day-to-day activities: the EU MDR and MDSAP.

This seminar will focus on the quality aspects of the EU MDR and MDSAP and
include a series of presentations addressing quality management system
processes, UDI, facility registration, market authorization and adverse
events, as well as an overview of where and how the two topics crossover and
their requirements intersect.

When: Wednesday May 9, 8:00 am to 12 noon.

Where: St Cloud State at Plymouth, 9750 Rockford Road, Suit 100, MN 55442

Who Should Attend: Engineers, Management, and other Employees responsible for Quality, Reliability, Regulatory, Production, and Development at Medical Device Manufacturers.  Suppliers, Contract Manufacturers, and persons interested in the Biomedical Industry will also find this workshop valuable.

Cost:  -Minnesotregister buttona ASQ Member – $125

-ASQ Enterprise Member- $125

-Non-Member – $150

Continental Breakfast is included: Breakfast will be served beginning at 7:30

Certificates of Completion: Issued on workshop completion for 0.3 ASQ RUs or 0.3 CEUs.


Mark Swanson, President of H&M Consulting Group, LLC. 

Lena Cordie, President at Qualitas Professional Services, LLC.