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). Credentials: certified Quality Auditor (CQA) for 10 years and Certified Biomedical Auditor (CBA) for 8 years with ASQ (American Society for Quality). Established, audited and improved dozens of quality management systems in compliance with FDA QSR, ISO 13485, as well as OUS regulatory requirements such as the European Medical Device Regulation 2017/745 for CE mark.
Engineering Solutions for a Better Tomorrow
Inquiry
Copyright © 2024 Nirin Development Inc - All Rights Reserved.
Powered by GoDaddy
This website uses cookies.
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.