Resources – Quality

 

 

Quality

Chris Bouchee – Medical Engineering Consultants (MEC)

Medical Engineering Consultants (MEC) is a consulting and training firm that provides services that cover design and development, quality management systems (QMS), manufacturing, and regulatory submissions.  These services range from individual contributors to full scoping, staffing and execution of small or large scale projects.  Our founders are industry veterans with over 40 years’ experience in R&D, Operations, Quality and Regulatory roles and truly understand your individual project needs.

Please get in touch to discuss your consulting, contracting or training needs!

  • Design Controls – Design Verification and Validation
  • QMS Implementation, Gap Assessments and Closure
  • Project Management – Custom Tailored to your needs
  • Regulatory Pathways – Submission Type and Strategy
  • Training and Organizational Change Management

View Medical Engineering Consultants Website

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George Martinez

ICON is the first medical device training center specializing in manufacturing and R&D. We offer hands-on training for your incoming or current employees on the essential tools and techniques used in the medical device field. Our goal is to have your employees familiar with the tools and processes you require when they enter your production area.  With professionally trained employees, quality increases and rejects and scrap decreases. We offer custom courses specifically designed to meet your needs. ICON can also assist with process transfers and process development. At ICON we are dedicated to helping you provide quality products to your customers.

View George’s Website

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Ross Meisner

We can help you better understand your competitor’s technologies and strengthen your FDA applications to achieve a faster approval. Questions we can help you answer include: Who else is in the market? What quality problems have they had? Which predicates should we use?

Basil Systems modernizes how RA/QA teams and business leaders can accelerate FDA submissions, streamline post-market surveillance, and inform competitive due diligence. By using our SaaS platform, companies, investors, and RA/QA consultants can quickly master these questions and the relevant regulatory landscape in record time. Basil helps you find all related products, visually navigate the 510(k) ecosystem, and plumb the details of PMAs, De Novos, and HDEs with just a few clicks. We make it easy to find product recalls and research adverse event trends and causes. In addition, we serve up related clinical trials and provide time-to-approval statistics to help get your product to market faster.

View Basil System’s Website

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Kristin Mortenson 

The foundation for bringing medical products to market began with a Bachelor of Mechanical Engineering, from the University of Minnesota Twin Cities, and continues to this day with ~30 years of industry experience and continuing education. The combined experience bridges across Research, Design, Development, Quality, and Regulatory through a broad range of products and companies ranging from small to large multi-national. Specializing in start ups, and using project management practices for product development, utilizing design control steps and integrated risk management.

View Kristin’s Website

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Anne Quinlan-Smith

Is the Sr. Vice President of Quality, Regulatory and Clinical Affairs at Surgical Information Sciences. Anne is an experienced Division President with a demonstrated history of working in the medical device industry. She is a strong business development professional skilled in U.S. Food and Drug Administration (FDA), Clinical Research, Medical Devices, Life Sciences, and CRO Management. Anne understands corporate goals to plan practical regulatory strategies, and has experience developing clinical study designs to collect clinical evidence and reimbursement data supportive of regulatory and reimbursement strategies. She can help you budget for clinical, regulatory and quality costs and prepare for meetings with Regulatory Agencies.

View Anne’s LinkedIn Profile

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