Customised trainings on European regulatory aspects
Regulatory trainings for the people who actually touch your file — regulatory affairs, QM, R&D leads, PRRC candidates and management representatives. Topics span CE marking, MDR and IVDR conformity, ISO 14971 risk management, clinical evaluation, vigilance and post-market surveillance, CAPA, ISO 10993-1 biocompatibility, EN ISO 13485 QMS, PRRC duties under MDR / IVDR Article 15, and German medical-device-consultant duties per §83 MPDG. Delivered in-house or as open seminars — tailored to your device class and to the auditor questions your team is actually being asked, not a generic syllabus.
Topics we cover
Eleven core training modules — delivered remotely or on-site, tailored to your team's level and product class.
CE marking
CE marking of medical devices and IVDs under MDR / IVDR.
Technical documentation
Preparation of technical documentation in line with regulatory requirements.
Risk management
Risk management according to ISO 14971.
Clinical evaluation
Preparation of clinical evaluation for medical devices.
Post-market surveillance
Post-market surveillance activities throughout the device lifecycle.
Vigilance
Vigilance requirements under MDR / IVDR.
CAPA handling
CAPA system handling for non-conformities and continuous improvement.
Biocompatibility
Biocompatibility requirements and testing strategies.
Quality management
Quality management systems according to EN ISO 13485.
PRRC role
Person responsible for regulatory compliance (PRRC) according to Art. 15, MDR / IVDR.
Medical device consultant
Medical device consultant according to § 83 German Medizinprodukterecht-Durchführungsgesetz (MPDG).
Your questions about trainings & workshops
MDR / IVDR essentials, EN ISO 13485 requirements, technical documentation, CE marking, post-market surveillance, vigilance, clinical evaluation, supplier audits, MDSAP — plus customised topics on request.
Both. We deliver on-site at your facility or remotely via video conference. Hybrid format is also possible when teams are spread across locations.
Yes. We tailor content to your device class, target markets, and the regulatory baseline of the audience. Standard slide decks are starting points, not the final version.
Recommended attendees: regulatory affairs, quality management, R&D leads, manufacturing process owners, post-market surveillance staff, and management representatives.
Single-topic workshops: 2–4 hours. Comprehensive MDR / IVDR primers: 1–2 days. Multi-day deep-dives are also possible for QMS implementation projects.
Yes. Each participant receives an MT Promedt certificate of attendance with the training content and date — suitable for inclusion in your QMS training records.
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Trainings & Workshops — German
Need a customised training for your team?
On-site or remote — get a training proposal tailored to your team's level and product class within 24 hours.