Neurovascular Access Devices, Neuro and Urological Ablation Devices, 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), Enteral Feeding Pumps, Feeding tube/catheters (nasogastric, gastric and jejunal implants)
Kristin M Mortenson
Specialties
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.
Foundation
612.202.1142
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.
As a Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) since 2004 with ASQ (American Society for Quality), we will 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 European Medical Device Regulation 2017/745 for CE mark.