Qrcompliance

QRcompliance is a consultancy offering QA/RA expertise in the field of IVD medical devices. Consulting Services QRcompliance can support with the composition / compliance review of your technical documentation against the MDR / IVDR. For instance, review whether your IFU and labels meet all the general safety and performance requirements. The EU regulations include quality system requirements, QRcompliance can help with the planning, implementation and maintenance of your company’s Quality Management System (QMS) against the ISO13485:2016 or other standards. Auditing Services Quality audits are an essential part of any effective QMS, with the purpose to verify the compliance of the Quality System to the applicable requirements. Companies operating in the field of (in vitro diagnostic) medical devices are required to have an internal and supplier audit program in place. QRcompliance offers auditing services to support you in the execution of your company’s internal and supplier audit program. Training Services In a rapidly changing world, where regulations and standards evolve and customer expectations keep rising, the continuous development of your professionals is of indispensable value to stay competitive. Do you want to improve the quality awareness of your employees, learn your professionals how to apply the requirements from the ISO 13485 or have another training need? QRcompliance can build and conduct tailored training programs.