At Deviceology, we establish strategic partnerships with clients innovating in the field of Medical Devices. We spearhead our clients compliance activities, providing comprehensive guidance through intricate international and local standards.

 

Our expertise encompasses ISO 13485 for Quality Management Systems and ISO 14971 for Risk Management in Medical Devices, as well as regional regulations such as Medical Devices Regulation in the UK and EU, ANVISA in Brazil, PMDA in Japan, FDA Regulations in the US, Health Canada's Medical Device Regulations, and the Therapeutic Goods Administration (TGA) standards in Australia.

 

Our services facilitate global market access by helping clients adhere to Regulatory obligations, International Standards, and Local Market Requirements (LMRs). We currently specialise in supporting access to the UK, EU, US, Brazil, Japan, Canada, and Australian markets and are working towards expanding this list soon.