Regulatory compliance consulting for IVDs

IVD Registration

The Global Harmonisation Task Force and many country-specific regulations have separate classification systems for IVD devices, typically based on risk to the patient.

It can be a confusing and difficult exercise to determine which classification your device falls into within each different set of regulations. For example, the GHTF classifcations are:

CLASS		RISK LEVEL	EXAMPLES
A	Low Individual Risk and Low  Public Health Risk		Clinical Chemistry Analyser, prepared selective culture media
B	Moderate Individual Risk and/or Low Public Health Risk		Vitamin B12, Pregnancy self testing, Anti-Nuclear Antibody, Urine test strips
C	High Individual Risk and/or Moderate Public Health Risk		Blood glucose self testing, HLA typing, PSA screening, Rubella
D	High Individual Risk and High Public Health Risk		HIV Blood donor screening, HIV Blood diagnostic

Using our extensive experience and regulatory contacts, we can help you work out the right classification for your IVD and prepare the dossiers that need to be submitted to the regulatory bodies.

IVD Manufacturing licences

We can assist in setting up the systems needed to get the appropriate certifications from regulatory bodies. Typically, an ISO 13485 compliance Quality Management System (QMS) is required for IVDs. We can help you build one from scratch or fix the one you already have.

Compliance problems

If you are preparing or recovering from a regulatory audit, we can help you determine your level of compliance and/or solve specific GMP compliance issues. This may include conducting a mock audit or reviewing the findings from a regulatory audit to determine the best course of action.

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Please contact us to discuss your needs or to obtain a quote.