We generate for you individual trainings for ISO 13485, MDR, IVDR, MDSAP and risk management.
As required we combine for you ISO and regulatory topics in one training.
We generate your training in the desired length.
We train you onsite or remote as desired.
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.
We take over the duties as EU Representative or UK Responsible Person for your company.
We support you in the communication with authorities.
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.
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.