The development of a sound device classification assessment and rationale is an essential starting point for medical device and IVD manufacturers and/or sponsors.

Our device classification will:

• Research the device classification in accordance with the regulations for the nominated region(s).
• Identify the classification rules which apply to your device(s) based on the manufacturers intended use.
• Consider specific guidance documents issued by regulators, notified bodies, competent authorities etc.
• Provide your organisation with the medical device and/or IVD medical device regulatory classification rationale.

Contact us for a custom quote.

Have a few questions? Visit our Frequently Asked Questions page.