About Us
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 brings extensive experience in scientific and regulatory affairs, having supported over 250 regulatory submissions and contributed meaningfully to the industry. As part of the MHRA’s ventilator taskforce, SciMed conducted Clinical Evaluations for the UK Emergency Ventilators used in Nightingale Hospitals. Recognized among the UK’s 75 leading healthcare organisations, SciMed was also featured in a book celebrating 75 years of the NHS.
Industry Participation
Our MD (Dr Alastair Selby) works in standard development, is a panel member on the production of a forthcoming Clinical Evaluation standard and has contributed to the recently updated Risk Management, Biological Evaluation & Post-Market Surveillance standards. He also sits on the UK Government’s All Party Parliamentary Group on Access to Medicines and Medical Devices.
Why SciMed?
Regulatory Expertise
SciMed are first and foremost recognized regulatory thought leaders. We work with the MHRA on humanitarian projects, come recommended by the ABHI, are speakers on the international conference circuit and our MD sits on Medical Device & IVD Standard Committees, and a UK Parliamentary Advisory Group. We are also proud to have been consistently presented a number of awards for our Regulatory Expertise.
Academic Heritage
SciMed has strong foundations in a variety of Life and Physical Science disciplines. This heritage means we have an excellent knowledge in a broad range of clinical specialties and product areas; knowledge we utilize to the regulatory benefit of our Compliance Partners [clients].
Scientific Proficiency
SciMed understand evidence & data and can therefore evaluate all information in an appropriately rigorous manner. This makes all our conclusions meaningful and robust, as well as being applicable across all regulatory processes.