Nirin Inc. knows that getting a medical device to market is more than designing a gadget. We work with our clients to create a safe and effective product that meets the user’s needs and complies with the regulations.

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My Foundation

Resorbable Embolic Microspheres, Hand held IVDs, Electromagnetic Navigation Bronchoscopy (ENB) devices, Orthopedic & Spine, Surgical- General and Laparoscopic & Implant Instruments & Accessories, Single Use & Reusable devices, Combination (Drug/Device/Biologic), Respiratory Ventilators, Pulmonary/ Vascular Catheters and Implants, Diagnostic Systems, Urological catheters & implants, Radiofrequency (RFID) Devices, Software-only Devices – PAC (picture archival and communication), Enterral Feeding Pumps, Feeding tube/catheters (nasagastric, gastric and jejunal implants)

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My education began with a Bachelor of Mechanical Engineering, from the University of Minnesota Twin Cities, and continues to this day in industry and continuing education. As a medical device engineer, with over 26 years of combined experience in R&D and Quality/ Regulatory Compliance in the medical device industry, I specialize in the project management of product development, utilizing design control steps and integrated risk management.

Beginning as a design engineer for the first half of my industry experience, I moved to add Quality and Project Leadership roles to my design and development skill set. As a Certified Quality Auditor (CQA) since 2004, I establish, audit and improve quality management systems in compliance with FDA QSR, ISO 13485, and ISO 9001, as well as OUS regulatory requirements such as the MDD Essential Requirements 93/42/EEC (for CE mark), and Canadian MDR. I also conduct training seminars for cGMP as well as specific design controls lectures at the University of Minnesota for the Biomedical Engineering Senior Design Course (BME4002).

Kristin M Mortenson