Medical device compliance
made easy.

We aim to solve your regulation, compliance, digital clinical safety and AI governance challenges, so you can focus on innovation. 

The Market Access People

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We’re on a mission to democratise medical device compliance and regulation.  We’re passionate about doing the right things, the right way. 

We pledge to share our expertise where possible and provide support when needed to help innovative medical device companies get their products to markets faster, and cheaper, to drive better health outcomes. 

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Our services

We facilitate market access by making available resources to help device manufacturers navigate the complexities of regulations and compliance, and providing support and guidance where needed.

We currently specialise in supporting access to the US, EU, UK, Brazil and Canadian markets and are working towards expanding this list soon. 

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Latest news

Unsure about medical device labelling?

Accurate labelling of medical devices is vital for the safe and proper use of medical devices by patients and care givers and is a key thing to get right when bringing a product to market.  ISO 13485 considers medical device labelling includes the label, instructions for use, and any other

Read More »

Market Access

Where will you go next?

Deviceology is primed to assist clients in successfully entering the UK’s  medical devices sector.

Our team of experts can help you meet the stringent MHRA regulatory requirements. Our regulatory specialists can build your Product Technical Files, identify an appropriate Notified Body, represent you at the certification audits and help you gain your UK CA marking.

Deviceology is adept at steering clients through the European Union’s medical devices landscape. Capitalising on our experience with international regulations and ISO standards, notably ISO 13485 for quality management systems, we deliver a full spectrum of services to simplify your market entry.

Deviceology and its partner network is well-equipped to guide clients through the U.S. FDA market access pathways including de novo, 510k and exemptions, pre-submission representations, QSR and and ISO13485 compliance.

Deviceology is uniquely positioned to assist clients in navigating the complexities of the Brazilian Medical Devices market. Leveraging our extensive expertise in international regulations including RDC 16/2013 for Good Manufacturing Practices (GMP), we offer a comprehensive suite of services that facilitate market entry.

With our partners, Deviceology excels in guiding clients through the multifaceted and promising landscape of Japan’s Medical Devices industry. Drawing on our deep-rooted expertise in international regulations and ISO standards, particularly ISO 13485 for quality management systems, we offer an array of services to ease your market entry.

Deviceology  can guide clients through the intricate landscape of Canada’s Medical Devices sector. With a strong foundation in international regulations and ISO standards, including ISO 13485 for quality management systems and PIPEDA privacy requirements, we provide services  to ease your entry into the market.

Deviceology is uniquely positioned to assist clients in navigating the complexities of the Australian Medical Devices market. Leveraging our extensive expertise in international regulations and our partner network, our services facilitate market entry.

The global Medical Devices market is a growing sector, expected to exceed $600 billion by 2025. This growth is propelled by technological innovation, an aging global populace, and escalating healthcare expenditures.

We have a network of partners specialising in local market regulations.

Careers

Helping our clients enter new and exciting markets requires people from a wide range of disciplines and backgrounds.

Get in touch

We’d love to hear from you.

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