Mark Swanson Regulatory and Quality Solutions

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark!

Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing company-wide capability. Mark will certainly be seen and heard across Minnesota on behalf of R&Q, starting today at MD&M Minneapolis!

Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE).

Read on as we ask Mark three questions about his work on the ISO Technical Committee and shed light on his background/experience.

About Mark

Mark’s career spans more than 16 years in medical device quality, quality management systems and regulatory compliance. The past four years, Mark has been the President and lead consultant of H&M Consulting Group; a group focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge and expertise as the large medical device companies. In addition, he is the Director of the Medical Technology Quality (MTQ) Graduate Program at St. Cloud State University.

Prior to this, Mark was part of Medtronic’s CardioVascular Group quality organization for a bit more than 12 years and an active member of their Risk Management Council developing systems for compliance to ISO 14971 and other quality management systems/risk management processes. And as previously mentioned, Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE).

Mark is an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485 that was published as ISO 13485:2016 and also participated with ISO TC176, WG24 on the 2015 versions of both ISO 9001 and ISO 9000. He currently is the project co-lead for the development of the ISO guidance document for ISO 13485:2016. The work with ISO includes discussions regarding ISO 14971, the European Medical Device Regulation and other international standards and regulations for medical devices, including work by the International Medical Device Regulators Forum (IMDRF).

In his work at St. Cloud State University, Mark has been a key driver of development of program and course learning objectives as well as working to match the program curriculum to medical device industry competencies for quality professionals.

3 Questions: ISO Technical Committee

R&Q: Glad to have you onboard, Mark! What was it like to work on the ISO Technical Committee?

mark swanson headshot medical device consultingMark: The work on the ISO technical committees is what many would consider ‘boring’. They are long meetings with lots of people (industry experts) around a very large table, or even what amounts to a large classroom discussing technical content of the standard. To me this is an extremely interesting process - to decide what can be agreed upon between not only industry and regulators, but what each country can support. Imagine having 30 to 40 experts in a room and getting them to all agree upon the requirements. Unsurprisingly, you often have to settle for ‘I can live with that.'

R&Q: What is the exact purpose of that committee?

Mark: The purpose of the ISO Technical Committee is to organize a group for development or revision of the industry standards. The main group I have been part of is Working Group 1 (WG1) of Technical Committee 210 (TC 210). This group has been responsible for the creation and revision of ISO 13485 which is the quality management system standard for the medical device industry. In addition, I also had an opportunity to be the liaison between TC 210 and TC 176. This is the technical committee responsible for the ISO 9000 family of standards. Through this I had an opportunity to work on the recent updates of ISO 9001, as well as ISO 9000, both of which were published last September.

R&Q: How does the committee enable you to advocate for industry?

Mark: Working within the ISO working groups provides an opportunity to give a voice to industry as the requirements are drafted. As you work within the group to help others understand the cost of implementation of a new requirement and the point of view from industry, you start to realize the impact you can have. In addition, I have come to realize the huge amount of both knowledge and expertise in applying that knowledge that has come from being present in the process, and now being able to bring that out to companies as we work with them to implement the requirements of the standards. Knowing the intent is without question a very powerful ally in this endeavor.

Be sure to check out R&Q's 10 Tips for Adopting the Updated ISO 13485:2016 Standards and case studies.

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