It is sometimes unclear as to the appropriate legislation to cover different devices in different markets but we have extensive experience on advising on these areas and the classification of the products.
We can provide advice and assist with the data requirements, regulatory activities/applications and liaise with the appropriate regulatory bodies to ensure medical devices are approved by Notified Bodies where needed.
We have experience in developing and implementing quality systems such as ISO 13485 and producing appropriate Technical Files and Clinical Evaluation Reports in support of CE or UKCA marking with all classification levels.
Medical Device market surveillance including Incident Reports and Field Safety Corrective Actions can also be undertaken.
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If you would like to find out more about any of our services please fill out the form below. We would love to here from you.