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Articles by Mark
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Risk Based Approach (Thinking)---NOT Risk Management
Risk Based Approach (Thinking)---NOT Risk Management
By Mark Swanson
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ISO 13485:2016-A Risk-based Approach to Your QMS Implementation
ISO 13485:2016-A Risk-based Approach to Your QMS Implementation
By Mark Swanson
Activity
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“Get closer than ever to your customers. So close, in fact, that you tell them what they need well before they realize it themselves.” — Steve…
“Get closer than ever to your customers. So close, in fact, that you tell them what they need well before they realize it themselves.” — Steve…
Liked by Mark Swanson
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There are many things I find exceptionally rewarding about my job but one of my favorites right now is getting to serve as the sponsor of the Twin…
There are many things I find exceptionally rewarding about my job but one of my favorites right now is getting to serve as the sponsor of the Twin…
Liked by Mark Swanson
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Check your pantries, people. 🥔 😜 #ThursdayVibes #EatYourVeggies
Check your pantries, people. 🥔 😜 #ThursdayVibes #EatYourVeggies
Liked by Mark Swanson
Experience & Education
Licenses & Certifications
Volunteer Experience
Publications
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White Paper on changes to ISO 13485
British Standards Institute (BSI)
Projects
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Quality Systems Implementation
- Present
Implementation of a Quality Management System that is compliant with US CFR and ISO 13485 is a large task that can require numerous resources and broad experience in areas of Quality.
Organizations
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American Society for Quality
Senior Member
- PresentOrganization dedicated to quality initiatives and professional development including certifications.
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American Legion
Post Commander, Finance Officer, Adjutant
- PresentAmerica's Largest Veteran's Organization. The Becker, MN "Oscar Peterson" Post 193 was founded in 1920 and is one of the oldest in the state of Minnesota.
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US Expansion in Engineering Biology & Industrial Biotech. A huge thank you to Jim Pickles, Ludovica A., Grace Looi, Bruce Colley, Hugh Bowen, Oliver…
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I am excited to share that I recently graduated from the FDA/CDRH Leadership Readiness Program. I'm extremely grateful and humbled to have been part…
I am excited to share that I recently graduated from the FDA/CDRH Leadership Readiness Program. I'm extremely grateful and humbled to have been part…
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🎙I’m excited and honored to share my interview as a guest on Vicki Noethling's podcast, "The Find Your Leadership Confidence Podcast" about…
🎙I’m excited and honored to share my interview as a guest on Vicki Noethling's podcast, "The Find Your Leadership Confidence Podcast" about…
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Join our QRx Partner, Steve Gompertz, and Naveen Agarwal, Ph.D., tomorrow morning for a 30-minute podcast on applying a risk-based approach to…
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🖋 It really does pain us to see companies get Warning Letters not just because of the original violations observed in an FDA inspection, but also…
🖋 It really does pain us to see companies get Warning Letters not just because of the original violations observed in an FDA inspection, but also…
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The Minnesota Biomedical Consortium is holding a class on August 20th: Guerilla Tactics for Quality Leadership: Getting Things Done Without Formal…
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