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.

Mission Statement

Specialties

Contact Information

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