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About Us

The Market Access People

At Deviceology Ltd, we are your strategic partners in achieving comprehensive market access for medical devices. Specialising in ISO 13485 and ISO 14971, our services extend beyond regulatory compliance to include authorised representative services, acting as your liaison to regulatory authorities. We manage your medical device registrations, market vigilance, and adverse event reporting, ensuring that you maintain full control of your device registrations. Our expertise spans international and territorial regulations, including the UK and EU's Medical Devices Regulation, ANVISA in Brazil, PMDA in Japan, FDA Regulations in the US, and Health Canada's Medical Device Regulations.

Our holistic approach ensures that you not only meet regulatory obligations but also gain a competitive edge in the market. With offices in key locations such as Europe, South America, and Australia, we can act as your in-country representative in these regions. We maintain robust partnerships with local agents in regions where we have yet to establish offices, serving as your liaison to manage these local partnerships on your behalf. This eliminates the need to deal with multiple distributors and vendors for different services and territories.

 

Whether you are a start-up entering the medical devices market for the first time or an established enterprise aiming to expand, our tailored services equip you to meet the unique challenges of the constantly evolving regulatory landscape. Our vision is to set new benchmarks in healthcare innovation, one compliant and intelligent medical device at a time, serving as the preferred regulatory partner for global market access.

Our Story

Founded by two seasoned professionals with extensive experience in technology delivery, innovation, compliance, and market access, Deviceology was born out of a passion for transformative healthcare.

 

Our co-founders have diverse backgrounds, having worked in start-ups, scale-ups, SMEs, multinationals, and government agencies. This blend of experience has imbued us with a unique perspective on the challenges and opportunities in the healthcare sector, particularly in the realm of medical devices.

We believe that the field of medical devices holds immense potential for groundbreaking healthcare solutions in the coming decades. With this vision, Deviceology was established to serve as a catalyst for innovation. We aim to streamline the regulatory and standards compliance process for healthcare innovators, thereby alleviating the administrative burden on their teams and enabling them to focus on what they do best: innovate.

 

A core part of our mission is to support the democratisation of healthcare, making advanced medical solutions accessible to all.

While we may be a young company, our rapidly expanding team brings a wealth of experience to the table. We are committed to leveraging this expertise to contribute meaningfully to the advancement of this exciting sector, for the greater good of healthcare and society at large. And remember, we are just getting started.

Our Offices

Deviceology - The Brazil Market Access People

Rua Barão do Triunfo 818

 Brooklin Paulista

São Paulo, SP

CEP 04602-004

Brazil

Deviceology - The UK Market Access People

71-75 Shelton Street

Covent Garden

London

WC2H 9JQ

United Kingdom

Deviceology - The EU Market Access People

EU

Deviceology - The Australian Market Access People

Australia

Coming soon

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