64 Madan Road,
SciMed provide award-winning, high quality, bespoke compliance consulting services to the medical device, combination product, borderline product and in vitro diagnostic industries.
The SciMed team have extensive experience in a variety of scientific and regulatory affairs processes and have supported in excess of one hundred and fifty regulatory submissions, as well as making meaningful contributions to wider industry. As part of the MHRAs ventilator taskforce, SciMed conducted the clinical evaluations for the UK Emergency Ventilators that went to the Nightingale Hospitals, and their MD (Dr Alastair Selby) works on a number of standard committees, has contributed to the recently updated risk management, biological evaluation, and clinical investigation standards, and sits on the UK Governments all party parliamentary group on access to medicines and medical devices.
SciMed have expertise in seven core business areas: Clinical Affairs, Biological Safety, Risk Management, Regulatory Services, Scientific Services, Design Control, and Quality Management Systems, have experience in a broad range of technology areas and with all classes of devices and IVDs.