EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 18113-1 testing. This standard defines concepts, lays down general principles, and specifies essential requirements for information provided by the manufacturer of in vitro diagnostic (IVD) medical devices.
It specifies the responsibilities and general requirements for planning, conducting, evaluating and documenting a performance evaluation study by the manufacturer. It does not apply to certain IVD MDs or certain assessment plans for a particular use.
Where a manufacturer maintains a quality system, this standard addresses compliance with "design verification" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928, with particular regard to the nature and use of IVD MDs.
EUROLAB assists manufacturers with EN ISO 18113-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
