Medical Devices

FDA to establish Digital Health Advisory Committee
2023-10-31T11:28:00+00:00By Catrin Jackson
Optimal materials selection in medical device development – a proactive biocompatibility approach
2023-10-02T15:30:00+01:00By Jocivania Oliveira da Silva, PhD, Senior Consultant in MD/IVD and combination products and Marielle Fournier, PhD, Managing Director; both of White Tillet Cabinet, Paris, France.
Rapid COVID-19 breath test device shows promise
2023-08-04T15:02:00+01:00By Alan Booth
Regulatory challenges and opportunities facing hearing aid manufacturers in Europe
2023-08-03T15:00:00+01:00By Blathnaid Feldman
A year of clinical trials under IVDR:
a sponsor’s perspective
2023-08-03T15:00:00+01:00By Suzanne Jenkins, Sabina Patel, Roy Milner, Lena Jansson, Maria Fernandez, Marta Thomsen, Patrick Fivey, Joan Boren
Impact of clinical data requirements following EU MDR (2017/745) & Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)
2023-08-03T14:59:00+01:00By Andrew Jackson, and adapted for publication by Vinetta Brew
Dementia patients retain ability to learn using devices: study
2023-07-10T09:12:00+01:00By Daisy Edwards
Wearables can spot Parkinson’s up to seven years earlier
2023-07-05T14:19:00+01:00By Alana Smit
Change Across the Medical Device Landscape
2023-06-23T15:39:00+01:00
Medical device standards update
2023-06-23T14:00:00+01:00By Mehryar Behizad, Regulatory Director, Endomagnetics Ltd
Neuralink gets FDA approval for its first brain device trials
2023-06-06T11:27:00+01:00By Alan Booth
IMDRF: Origins, purpose and current work
2023-03-07T13:29:00+00:00By Mehryar Behizad
European medicines and medical devices: Future trends
2023-03-07T13:28:00+00:00
Understanding key components
of a clinical evaluation
2023-03-03T12:29:00+00:00By Angela Siebeneck
Regulation versus innovation in life sciences
2023-02-07T09:27:00+00:00By Richard Bassett
IVDs and medical devices — post-market surveillance and clinical follow-up requirements
2023-02-07T09:27:00+00:00By Kirsten Van Garsse
Successful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR
2023-02-07T09:25:00+00:00By Niamh Miller, Laura Taylor
November 2022 – Contents
2022-11-14T10:13:00+00:00
Medical Device Standards Update
2022-10-31T14:41:00+00:00By Mehryar Behizad
Navigating the MDR’s heightened surveillance and performance requirements
2022-09-16T09:25:00+01:00By Ana Quinn
EU expert panels for high-risk devices - another level of review?
2022-09-16T09:25:00+01:00By Colleen Watson, Frances J Richmond