In Vitro Diagnostics
Does your company need assistance in meeting the requirements of the European Regulation for In Vitro Diagnostics?
Qarad – part of the QbD Group – can explain the requirements, perform gap assessments of your QMS, review and/or compile your technical documentation, organize performance studies and act as your authorized representative in the EU.
Discover how Qarad, part of the QbD Group, can support your company in In Vitro Diagnostics below.
Challenges in In Vitro Diagnostics
The In Vitro Diagnostics industry is rapidly evolving thanks to technological innovations and new medical insights.
In 2017, the European Union published a new regulation for IVD, the IVD Regulation 2017/746. It represents a steep increase in the requirements, necessitating good regulatory competence and resource availability to keep the time-to-market as short as possible.
Qarad can assist your company in all your regulatory challenges from design to CE certification, from idea to patient.
Why Qarad, part of the QbD Group?
Qarad – part of the QbD Group – has a team of experts in quality assurance and regulatory affairs. Most team members had 10 to 30 years of experience in the In Vitro Diagnostics industry, before joining Qarad. We do not only fully understand the regulations, but also the different assay technologies.
Qarad is certified for ISO13485 and ISO27001 standards. The nomination for the TOPRA Award in the category Innovation recognizes that we provide practical tools for IVD manufacturers to cope with regulatory requirements. The technical documentation of the first Class C IVD ever certified by a notified body, was entirely compiled by Qarad.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.