MEDICAL DEVICES

Medical Devices European Market Overview

Medical devices has a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

Europe is a second largest market in the world behind the USA with 27% of the world market revenue. The  market size was estimated at roughly € 120 billion in 2018.

European Regulatory Framework

To keep up with advances in science and technology and to ensure better protection of public health and patient safety were adopted, On 5 April 2017, 2 new Regulations on medical devices and in vitro diagnostic medical devices establishing a modernized and more robust EU legislative framework. These 2 new Regulations (Regulation (EU) 2017/745 and Regulation (EU) 2017/746 are replacing the 3 existing Directives after a transition period (until 2022).

In addition, ISO 13485 is increasingly required, or at least beneficial as a standard of the Quality Management System accepted as the basis for CE Marking under European directives.

How can we support your business?

Stepwise can help you in the transition period of the European regulatory framework to make your medical devices company compliant with the new regulations.

Stepwise can assist you with facility design, processing technologies and distribution complying with regulatory requirements for Regulation ISO 13485:2016, EU-GMP, EU-GDP and FDA QSR 820 for medical devices.

Stepwise consultancy services can help you achieve design efficiencies, regulatory compliant processes and mandatory employee and contractor training. These quality management strategies help to ensure that your cosmetics products are suitable for the markets you aim to serve.

Stepwise can provide turnkey facilities design. Our approach to the facilities design, targets specifically for success intending to optimize efficiency and compliance. Stepwise uses Lean Manufacturing thinking to work with its customers and incorporate this into the facility design.

Stepwise’s range of services covers also Product Development support, Regulatory and Marketing services to assist clients in the route to market.

check all stepwise services here

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