Nometech Oy helps companies navigate quality management, product development, and regulatory challenges whether it’s a medical technology device or another type of product. 

We bring expertise in U.S FDA market, ISO 13485, MDSAP, CE marking under EU MDR 2017/745, development and validation of medical devices.

Beyond the medical device sector, we also support organizations in other industries with their quality management and regulatory needs, including the implementation and optimization of ISO 9001 quality management systems. 

Our services integrate trainings, quality consulting, regulatory compliance, and practical product development into a process that supports your project from concept to market and beyond. Whether you are developing a new product, enhancing an existing quality system, or navigating regulatory strategy, we are here to help you. 

Free 30-minute regulatory consultation ☕

FDA, ISO 13485 technical documentation or some other regulatory concern on your mind?
👉 Book a free 30-minute regulatory sparring session:

https://calendly.com/katja-koskinen-nometech/30min

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