The decision to amend the Regulation relieves pressure on national authorities, Notified Bodies, manufacturers, and other stakeholders.  Don’t be fooled, this is no time to relax your efforts to prepare. 

• Do you have a submission strategy, even with the updated proposed timeline?
• What is the common feedback on EU MDR submissions?
• What are common requests from auditors during reviews?
• What is the European database on medical devices and why is it important?

Come to quiz Renee, Jai & Mark on this ever-changing topic.     

Date:  Thursday, April 20th, 2023

Time:  6:00 pm CST - 8:00 pm CST

Location:   St. Cloud State - Plymouth 9750 Rockford Road, Plymouth MN 

Cost: -Minnesota ASQ Member - $20.00

          -Non-Members - $40.00

•   A light snack will be provided 

• Certificates of Completion: Issued via email, after workshop completion, for .2 ASQ RUs or .2 CEUs.

If you have any questions, please contact Karen Peifer at [email protected].

Instructor Bio’s

Mark Swanson

(ASQ CMQ/OE, CQE, CBA) is a Partner and leading consultant for Quality and Regulatory Expert Partners, LLC (QRx)

QRx is a partnership focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as large medical device companies. Mark has more than 23 years of experience in the medical device industry including all roles in quality. He is a senior member of ASQ and RAPS as well as a corporate AAMI member (serving on several AAMI committees).

Mark has spent the last several years as an active member of ISO Technical Committee 210 (ISO TC210), Working Group 1 (WG1) working on the revision of ISO 13485 that was published in March 2016, was the project co-lead for the guidebook on ISO 13485 and lead US member of Working Group 6 (WG6) on post-market surveillance (ISO TR 20416). He also participated with ISO TC176, WG24 on ISO 9000/9001:2015 and in the AAMI group responsible for TIR 102, to formally compare ISO 13485 to the US FDA Quality System Regulation. To add to this, Mark also participated in the US TAG for risk management (ISO 14971) and the workshop that created IWA 31 (agreement on the application of risk management in standards). In this work, he leads the discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.

Renee Cveykus
Sr. Manager – Regulatory Affairs Neurovascular, Medtronic

Renee Cveykus is a Sr. Manager Regulatory, Neurovascular (NV), at Medtronic. She joined the company in 2001 and held various positions before joining Neurovascular. In 2021, Renee joined the Neurovascular where she manages her team responsible for stroke products. Her main responsibilities include US & EU submission, direct correspondence with the FDA and notified bodies to bring products to market and IDE and Clinical Study support. In addition, she sets regulatory strategic direction, while driving efficiency and productivity for bringing new neurovascular products to market.

Before joining the RTG team, Renee held various Regulatory, Information Technology and Quality positions, including a Master Black Belt, Lean and Six Sigma at Medtronic. Renee was one of Medtronic’s first Certified Master Black Belts in Medtronic and holds the record for most completed Kaizens (30+) within Medtronic.

She is married and has four sons. Her hobbies include running, art and global travel.  Always open for a new experience, she loves the outdoors and her favorite race to date is the 198-mild Hood to Coast relay run in Portland, Oregon; a fundraiser for cancer.  Another favorite event was attending the Abu Dhabi 2019 Special Olympics World Summer Games as she watched her son complete in three track and field events.

Renee is a 2013 graduate from St. Cloud State University, St. Cloud, MN with a Masters in Regulatory Affairs and Services. 

 Jaishankar Kutty, Ph.D.

Vice President Of Intelligence & Innovation at RQM+

 In his previous role at BSI, he doubled up as clinical team lead and a technical team lead assisting a team of talented experts towards CE marking cardiovascular devices. This stint consistently helped broaden his understanding and appreciation of the most innovative technologies in the cardiovascular space. The team constantly strove to come to terms with the changes in EU regulations and the increased scrutiny around all aspects of biological safety, clinical data gathering/reporting and clinical evaluations. At St. Jude Medical, he was involved in the design, testing and development of significant surgical and transcatheter heart valve repair and replacement devices (concept to market) among other technologies such as septal closure, extravascular closure and renal denervation. As much as his doctoral research has given him a strong foundation in natural and synthetic biomaterials, cell & molecular biology and biomechanics; industry experience has made him appreciate how much more learning lies ahead. Learning and growing are non-negotiable, so, currently, he combines some of the significant EU regulator experience with expertise in cardiovascular devices towards helping medical device manufacturers in a clinical-regulatory strategic leadership role at RQM+.