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In the Medtech world medical device certification should stay on the entrepreneurial top of mind list to look after. What is the CE and Quality Management System (QMS) all about and how they affect medical device certification? Is certification of the system according to EN ISO 13485:2016 necessary during the certification of a medical device […]
The MedTech sector and healthcare have faced two years of extreme difficulty. The burden on the health system or missing components for device manufacturing are just the beginning of a list that touches these two areas. But 2021 is over. Hard times create a great opportunity to build and deliver innovative services and technologies so let’s dive into the future.
The Christmas season should mean something special. During that time we always want to do something good. How to match help with engineering? In December we decided to help not only financially but also in terms of skills. Our CSR activist, Krzysiek, suggested taking part in the “Szlachetna Paczka” project.
Medical gadgets belong to the broader category of consumer electronics related to bodily function and health management. Technologically innovative, they arouse interest primarily with their clever functions, compact size and modern design. Among them we find devices for relaxation, stress reduction and sleep monitoring, and those used in sports and recreation.
When launching a medical startup some might have a vision of a medical device on a store shelf. And that’s a good point to kick off. However medical projects are not as fast as lightning and both sites should think about it as a process that leads from that first perfect image to the certified medical product.