Technical Documentation & Clinical Evidence
Do you need support in preparing the Technical Documentation of your IVDs in order to comply with EU 2017/746?
Are you looking for expert advice on possible clinical evidence strategies for your IVD?
Or are you looking for a detailed assessment of your Technical Documentation before submitting it to a notified body (NB)?
Our device compliance team has the expertise to address any question or need related to Clinical Evidence and Technical Documentation of your IVD.i
Our device compliance services
With the introduction of the new IVD regulation, many IVD manufacturers are faced with a laborious process of writing documents to comply with the regulations.
Qarad is an expert in the field of in vitro diagnostic medical devices. We can support you with medical writing activities or with ad hoc expert advice:
- Compilation of STED (Summary of Technical Documentation)
- Review and gap assessment of STED
- Medical writing of clinical evidence documentation (including performance evaluation plan and report, analytical and clinical performance report
- Scientific validity documentation
- Summary of safety and performance
- Ad hoc consulting on clinical evidence topics
Why QbD Group?
The new regulation on in vitro diagnostics includes new requirements for the technical documentation and clinical evidence of IVDs.
Preparing for the new IVD regulation is a time-consuming process for IVD manufacturers. Qarad – part of the QbD Group – can relieve you by performing medical writing tasks and answering questions with expert input.
We have over 20 years of expertise with IVDs, ensuring advice and documentation that complies with the latest regulations and is tailored to your device.
Tailor-made IVD solutions
Our device compliance team offers tailor-made solutions. Together, we identify your needs and propose a service to address those needs.
Don’t hesitate to contact us if you have any need for IVD device compliance services. Our team of experts is happy to assist you!