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THE INNOVATIVE HEALTH ORGANISATION

Leading where others just follow


ABOUT US


The Innovative Health Organsiation works to improve people’s health through cutting edge innovation. By working together with both Businesses and Universities we are able to find sustainable solutions to the greatest global health challenges.  

Our work is focused on development, technological innovation, medical robotics, healthcare design and cutting edge research 

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EXPERIENCED, FRIENDLY STAFF

With over 20 years’ experience in designing, developing and testing healthcare products, we can be confident our staff will always give you a frank and honest assessment of what is required to ensure you products meet the highest clinical standards 









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Laboratory Clinical Trials

Although "new" may imply "better," it is not known whether the potential medical treatment offers benefit to patients until clinical research on that treatment is complete. Clinical trials are an integral part of new product discovery and development and are required before a new product can be brought to the market. Potential treatments, however, must be studied in a laboratory first to determine potential Risks before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials.

  

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 CE and MHRA Registration Processes


General’ medical devices are grouped into four classes as follows:
Class I - generally regarded as low risk
Class IIa - generally regarded as medium risk
Class IIb - generally regarded as medium risk
Class III - generally regarded as high risk


We can guide you through the process including creating your Technical files, Risk assessment, Medical Devices Directive (93/42/EEC), Med Dev 2.4.1., 60601 3rd Edition and a multitude of other documentation