Steve has extensive experience in Healthcare Regulatory Affairs, Quality Assurance, Project Management, Design and Development. Experienced in various medical technologies including drug/device combination delivery systems, borderline drug/devices, In-Vitro Diagnostics/companion diagnostics, general medical devices, medical electrical equipment, software medical devices, digital health including ‘Apps’, cosmetics, consumer health products and food supplements.
Setting the right standards
The theme of this issue is Global Standards but – as the contents reflect – the process by which documents and data become ‘standardised’ is anything but homogeneous or harmonised.
Great expectations for medical technologies
Few would dispute that the medical technology regulatory system continues to creak under the strain imposed by the regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746). At the time of going to print, the Medical Device Coordination Group (MDCG) issued proposed ...
The future of pharmaceuticals is green
The healthcare sector is not immune from societal concerns about the environment and will have to go green over the next few years