Bring your Product to MArket the right way
With expert project leadership, prompt quality management, and elite regulatory compliance to ensures the pieces fit together
Purpose
Our consulting firm offers medical device product development, with project management, quality management systems, and regulatory submissions and compliance.
Foundations
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.
Expertise
Specialties include project management of product development projects utilizing design control steps with integrated risk management (ISO 14971). Expertise includes design input / requirements, design output, project planning, design reviews, verification and validation protocols and reports. Additionally, as a Certified Quality Auditor (CQA) since 2004, we establish, audit and improve QMS (quality management systems) in compliance with FDA QSR, ISO 13485:2016 as well as OUS regulatory requirements such as the European MDR (medical device regulation) as necessary for CE mark, as well as Canadian MDR. I also conduct training seminars for cGMP, design controls. Another focus has been implementation of eQMS, electronic, paper-less QMS.
Engineering Solutions for a Better Tomorrow
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