We aim to solve your regulation, compliance, digital clinical safety and AI governance challenges, so you can focus on innovation.
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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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 specialise in UK, EU and US market access and are supported by our trusted partners to support other market access.
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
Where will you go next?
Deviceology is primed to assist clients in successfully entering the UK’s medical devices sector.
Our experts can help you meet MHRA regulatory requirements for UKCA marking and NHS compliance standards. Our regulatory specialists can build your product technical files, represent you through certification audits, and meet DTAC, DSPT and DCB patient safety requirements.
We can help you place your medical devices in European Union markets, with a full service to navigate and simplify your market entry.
We can guide you through the U.S. FDA market access pathways including 510k and exemptions, pre-submission representations, QSR and ISO13485 compliance.
Our trusted local partners are experts on Candian market acess including MDSAP and PiPEDA compliance.
With our trusted local partners and deep expertise in ISO 13485 for quality management and RDC 16/2013 for Good Manufacturing Practices (GMP), we offer a comprehensive suite of services that facilitate market entry.
With our trusted local partners, quality management and medical device compliance, we offer an array of services to ease your market entry.
With our trusted local partners, quality management and medical device compliance, we offer an array of services to ease your market entry.
Helping our clients enter new and exciting markets requires people from a wide range of disciplines and backgrounds.
We’d love to hear from you.
Simply fill out the form and we’ll get back to you as soon as we can.
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