Individual Training

We generate for you individual trainings for ISO 13485, MDR, IVDR, MDSAP and Risk management.
As required we combine for you ISO und regulatory topics in one training.
We generate your training in the desired length.
We train you onsite or remote as desired.

QMS Services

We assist you with the creation of your QMS documentation.
We check your QMS documentation for conformity with ISO and MDR, IVDR and MDSAP.
We carry out gap analyzes for you.
We serve you as required on site or online via video conference.

EU Representative /
UK Responsible Person

We take over the duties as EU Representative or UK Responsible Person for your company.
We support you in the communication with authorities.

Audit Services

We conduct internal audits for you.
We check your QMS documentation for conformity with ISO and MDR, IVDR and MDSAP.
We help you prepare for external audits and support you during the audits.
We serve you as required on site or online via video conference.

Technical Documentation

We help you with the creation of your technical documentation.
We check your technical documentation for conformity with MDR and IVDR.
We serve you as required on site or online via video conference.
Please contact us if you have any questions about our services and prices.