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Our medical device regulatory consultants have a wealth of experience in a wide range of device technologies from implantable devices to medical device software.
In most countries across the world there are specific regulatory requirements that govern the activities needed before a medical device can be marketed legally.
Arguably the two most important regulatory regimes are those in the EU and US, due to the number of patients these regulatory systems open a manufacturer up to both directly and indirectly via countries whose regulatory structures are in some way dependent on those of the EU and US.
The regulatory requirements for a particular medical device are based on a multitude of factors including the risk classification, intended purpose, type of technology and novelty of any features or materials.
Our medical device regulatory consultants have a wealth of experience in a wide range of device technologies from implantable devices to medical device software. As a medical device regulatory consultancy, we also have extensive experience of working to the EU and US regulatory requirements as well as those in over 50 other territories including Australia, Canada, China, Japan, Brazil, Russia and numerous countries in the Middle East, successfully completing registrations in each.
Our medical device regulatory consultancy services often start with the creation of a medical device regulatory strategy for the project, including the important activity of determining the classification of the device, whether according to the EU medical device directive (93/42/EEC), medical device regulations (MDR, (EU) 2017/745) or using the FDA classification database. These strategies always make use of the most up-to-date and relevant standards and guidance documents such as the guidance MEDDEVs for the medical device directive or the MDCG endorsed guidance under the MDR
Some of the more common medical device regulatory consultancy work that we conduct is the creation of medical device technical files or technical documentation, risk management activities including risk assessments, medical device clinical evaluation plans and reports and 510k submissions to the FDA.
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