Solutions Delivery Manager - Maetrics
David is a Solutions Delivery Manager at Maetrics with extensive experience as a medical writer, authoring numerous Clinical Evaluation Reports in a variety of medical device therapy areas. David is a clinical professional with a background in clinical affairs, clinical development and clinical research in both the Medical Devices and IVD industries.
At Maetrics, David has supported clients by providing comprehensive CER gap analysis and developing tailored CER strategies, for novel and legacy devices, to facilitate and confront the challenges of transitioning to the EU MDR. David is able to apply a high level of management acumen to drive clinical projects forward and to achieve project success.
Prior to joining Maetrics, David was a Clinical Affairs Manager for innovative IVD SME, Mologic Ltd, where he established a Clinical Affairs department utilizing his extensive clinical research experience and clinical development knowledge to provide support and strategic oversight through all phases of the product development life cycle.
1 blog from the author
Posted on 13.05.2019
IVDR: an overview of clinical evidence requirements
With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation’s transition period. A […]