“Our goals are to support the in-vitro diagnostics industry, from start-ups, distributors to multi-national manufacturers, to understand, evaluate and implement quality and regulatory compliance, to allow placing safe and effective diagnostics onto the market, and ensuring patient and consumer safety.”

Stuart Angell & Nancy Consterdine
Co-founders

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Update for SARS-CoV-2 classification update - read more about it here

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Need to appoint a UKRP? You can fill out our easy questionnaire for a quote here

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Regulatory Roadmap for Medical Devices published - read the breakdown here

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What Is An IVD?

In-vitro diagnostics (IVDs) are a specific type of medical device, used to test human samples (e.g. blood urine, saliva). These tests can be used by a healthcare professional, or a lay user, to detect, or monitor a physical condition or infection. IVDs play an important role in the diagnosis of illnesses and support further medical treatment.

Due to the importance of the result from these tests, the design and development of these devices are highly regulated to ensure patient and user safety.


Our Services

Regulatory

Expert advice from early design stages to placing devices on market throughout the world

Quality

Helping you understand, build and maintain your Quality Management System

UK Responsible Person

Helping non-UK IVD manufacturers register devices on the UK market

Want to know more…?

Contact Us Directly

[email protected]
Monday-Friday 8.30 – 5.00pm only
@ivdeology-ltd

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