FAQs

Answers to common questions about our services

How do I know if you can work with my device?

We can work with all device types & classes.
Will my enquiry be dealt with confidentially?

Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice.
How can I be assured of a quality service?

We have a 100% submission success rate under both EU MDR and EU IVDR, with a commitment to stand behind each and every submission until complete acceptance.
Do you work with medical software?

Yes. Software as a Medical Device (SaMD) is an increasingly-important segment of the market and we have extensive experience in building regulatory systems for medical device software.
Can you help us as an EU Authorized Representative & UK Responsible Person?

Yes. Whilst we don't act as representatives directly, we have a close working relationship with a carefully selected partners that can act as your EU Authorised Representative (EC REP), UK Responsible Person (UKRP) or Swiss Authorised Rep (CH-REP).

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