That’s right: we are happy to announce that Bureau Veritas Italia S.p.A. has certified that. Euleria Health’s Quality Management System complies with the requirements of the Regulation (EU) 2017/745 regarding medical devices that are close to being placed on the market.
Today, September 12, 2023, as we work on the official launch of the two newly certified medical devices, we asked Riccardo Dainese, CEO of Eumed and our Quality Advisor.
Riccardo, what does the industry landscape look like today?
R.D. [Riccardo Dainese, ed.]: “EU Regulations 2017/745 (MDR) and 2017/746 (IVDR) are undoubtedly bringing about major changes in the medical device industry, particularly as to the products and applications that are technologically more advanced, especially software, medical apps and related telemedicine services“.
Eumed has always supported companies engaged in the production and sale of medical devices. How?
R.D.: “Business operators and medical experts must at all times ensure the safe and effective performance of their medical devices while ensuring their effective availability in the market. Here, then, companies find in Eumed s.r.l. a strategic reference for all the obligations that the industry requires of them in terms of production, development, certification, import and distribution of medical devicescomfortable”.
What are the fulfillments required by the biomedical market from manufacturing companies today?
R.D.: “A large number of manufacturers, particularly small and medium-sized enterprises, are not sufficiently prepared to demonstrate compliance with the requirements of Regulation (EU) 2017/745, particularly when taking into account the complexity of these new requirements. It is therefore very likely that many devices that could now be brought to market due to certain transitional provisions are not certified in accordance with this regulation before the end of the transitional period. The challenge that awaits manufacturers and operators is therefore decisive and will bring out the most prepared and technologically advanced companies in the industry“.
Along your consultancy, which business compartments did you come into contact with in order to achieve the goal of CE compliance of products Euleria Health?
R.D.: “From the analysis of regulatory and design requirements for products and/or services, to checklists to verify these fulfillments, to reports, to technical files and to the system of procedures specific to the Production, testing, marketing, supervision and post-sale surveillance, we EU consultants and proxies come into contact with practically all business departments, with the aim of obtaining the maintain the compliance Of a medical device. Specifically involved are:
– management and apex figures
– those responsible for compliance
– the figures overseeing the design and manufacturing processes
– the HR involved in the logistics, marketing and sales departments“.
Thanks to Riccardo Dainese for this contribution.
