Case study 1
End-to-end support for manufacturers seeking Notified Body approval
We worked with a large multinational IVD manufacturer to progress all their IVDs through the EU IVDR process including transition of legacy devices and new devices up to and including Notified Body review and acceptance.
Case study 2
Integrating Clinical Study Plans across jurisdictions
We worked with a large global multinational to assist them to develop technical material that complies with both the extensive and complex EU IVDR and FDA technical requirements for IVDs.
In particular, this client needed assistance with integrating clinical study plans - being executed in both the US and EU - to ensure they fully met the legal requirements of both systems.
Case study 3
Peer-reviewed manuscript editing, support and submission
We assisted a large pharmaceutical manufacturer to prepare a collaborative multi-authored manuscript for publication in a major international journal.
In particular, against a very tight deadline we reviewed and amended several earlier submissions and turned around the text for publication within 7 days.
Case study 4
We provided training to senior management of a major US Pharmaceutical company on the new and emerging interface between Clinical Trials and the EU IVDR and the impact on clinical trials conducted in the EU.
In particular, we undertook work around the definition of medical purpose and are providing on-going technical consultancy to develop global SOPs that legally integrate clinical trials within the EU IVDR.
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