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We have a wealth of IVD consultancy experience in the development and regulatory conformity of IVDs across the globe, including obtaining notified body and FDA 510k approvals.
In vitro diagnostics (IVDs) are medical devices intended to be used for the analysis of specimens derived from the human body in vitro (outside the body).
The size and importance of the IVD market has been increasing in recent years due to numerous technological advancements such as in companion diagnostics and artificial intelligence. In addition, significant changes to the legislation governing IVDs in the EU has been brought about by the upcoming replacement of the in vitro diagnostics device directive (IVDD, 98/79/EC) with the IVD device regulations (IVDR, (EU) 2017/746 ) and this has led to a large number of additional IVDs requiring an assessment by a notified body.
We have a wealth of IVD consultancy experience in the development and regulatory conformity of IVDs across the globe, including obtaining notified body and FDA medical device 510k approvals. From the initial regulatory strategy through the development stages, on to the creation of a compliant and functioning quality management system (QMS) and obtaining the final regulatory approval, we can help in whatever area you need or can be your single source for handling all compliance activities for your project.
A large part of our IVD consultant work comes from the update and remediation of technical files or technical documentation, including risk management files and the performance evaluation plan and report. We continually keep abreast of recent developments and guidance from the European Commission and the MHRA, amongst others.
Our IVD consultancy services also include the submission of the dual 510(k)/CLIA waiver. We also keep up-to-speed with recent FDA developments in the regulation of IVDs.
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