Training courses

Qualified employees are the prerequisite for successful work. We support you with in-house training on a wide range of issues:

§  QM systems for medical device manufacturers, distributors and suppliers,

§  Risk management for medical devices according to EN ISO 14971,

§  Development of active medical devices in conformity with EN 60601-1,

§  Software development in accordance with EN 62304 and EN 60601-1, chapter 14,

§  Software validation in accordance with MDR, IVDR, FDA Design Control, EN ISO 13485, EN 82304-1, EN 60601-1, Chapter 14,

§  Interoperability of medical devices according to ISO/IEEE 11073, AAMI/ANSI/UL 2800, DICOM, HL 7,

§  Usability in accordance with EN 60601-1-6 and EN 62366-1,

§  ISO/FDA-compliant product and software development (design control),

§  Regulatory affairs training for worldwide approval,

§  Post Market Surveillance, Vigilance and Post Market Clinical Follow-up,

§  Person responsible for regulatory compliance (Responsible Person) according to Article 15 MDR/IVDR,

§  German Medical device advisor according to § 83 MPDG,

§  Internal and supplier auditor training and

§  Training on conducting clinical assessments in accordance with MDR and MEDDEV 2.7/1 Revision 4.