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 have extensive experience in a variety of scientific and regulatory affairs processes and have supported in excess of two hundred and fifty regulatory submissions, as well as being recognised and 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. SciMed have been recognised as one of the 75 leading organisations within the UKs healthcare framework, and even featured in a book commemorating 75 years of the NHS.
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.
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.
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.