At Deviceology we provide International Standards certification and Regulatory Support for Medical Device Manufacturers and Health IT providers, leveraging our experience across diverse complex projects. We provide standards certification, regulatory strategies, market access, reimbursement models, product registration and post market surveillance for major markets including the U.S., Europe, UK, Australia, Brazil, Canada, and Japan. Our expertise spans physical devices, Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD), offering services for advanced technologies.
The two co-founders of Deviceology have more than 25 year of experience each in I.T., Standards and Audit. We are seasoned professionals who have created Deviceology to support organisation with innovative products and services meet their compliance obligations in a way that strengthens and supports the organisation rather than being seen as a burden or hurdle. We have built a multidisciplinary team around us of specialists in key areas of compliance to offer a professional service at a price point that is affordable.