Consulting Services

QRcompliance Consulting Services ranges from quality policy advice to hands-on support, in the field of quality assurance and regulatory affairs.

Quality Assurance

Quality Assurance

Quality Assurance

The regulations for (IVD) medical devices include quality system requirements. The EN ISO 13485:2016 standard is recognized as a harmonized standard for (in vitro diagnostic) medical devices, in support of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/246 (IVDR).

QRcompliance can support you with the planning, implementation, maintenance and improvement of your company’s Quality Management System (QMS) to meet the requirements laid down in the IVDR / MDR, ISO 13485:2016 or other standards.

Depending on the situation, QRcompliance is able to set up a complete new quality system or suggesting only essential improvements to an existing Quality Management System. Furthermore, QRcompliance can provide training, perform a compliance scan, give ad hoc advice or manage your quality system on a permanent basis.

CE marking

Regulatory Affairs

Regulatory Affairs

An (in vitro diagnostic) medical device must bear a CE mark when sold in the European Union. By placing the CE mark on a product, the legal manufacturer declares that the product complies with the European regulation for IVD medical devices (Regulation (EU) 2017/246) or medical devices (Regulation (EU) 2017/245).

Technical Documentation

European regulations require a comprehensive technical file for each (IVD) medical device. QRcompliance can support you in in the review / composition of the technical documentation. Take a look in our shop for digital downloads to support the compliance of your documentation.

Instructions For Use and labels

Compliant labelling is an important requirement when placing your (in vitro diagnostic) medical device on the market!  QRcompliance reviews whether your IFU and labels meet all general safety and performance requirements from the IVDR / MDR.