Training
AKRA TEAM bietet verschiedene Online- und Offsite-Schulungen und Webinare zu ausgewählten Themen im Bereich der regulatorischen, qualitätsbezogenen und klinischen Angelegenheiten an.
Anstehende Schulungen und Webinare
High Quality Templates
Check available TD Templates
- Download Area
Benefit from our experience in conformity assessment processes
Joint Onsite-Workshop on
Drug-Device-Combinations
Onsite in Munich
- 2025-03-10
- 2025-06-30
How to successfully navigate the Drug-Device Combination Products Landscape
Usability of Medical Devices
Webinar
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Regulatory requirements and practical tips
Clinical Evaluation and Clinical Evidence for Medical Devices
Online Seminar/Training
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Regulatory requirements and practical tips
SSCPs - An easy approach to be Compliant
Online Seminar/Workshop
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Drawing-Up MDR compliant SSCPs: Pitfalls & Solutions
PMS-System under MDR - A structured Overview
Online Training
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A structured overview of PMS-PMCF-PSUR
Clinical investigations according to ISO 14155
Online Seminar/Training
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Interrelation to EU-MDR & MDCG Guidances
Drug-Device-Combinations - A comprehensive Overview
Online Training
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Overview of product categories & regulatory requirements (incl. Article 117)
Literature Search for the Clinical Evaluation
Online Training
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Overview, requirements and structured, stepwise approach for SOTA and S&P
UKCA - An Introduction
Online Training
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Detailed overview of the UK MDR, current regulatory landscape and upcoming changes
MDR compliant QM-Systems
Online Training
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Important aspects to avoid pitfalls
TD and Riskmanagement
Online Training
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Interelation between TD and ISO 14971
MDR Basics
Online Training
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Understanding the structure & requirements
Auditing Clinical Aspects of the MDR
Onsite Training
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Auditing Clinical Aspects of EU-MDR and related MDCG Documents
Support & Training
Sie haben nicht das richtige Training für sich gefunden und sind an einem Angebot für ein spezifisches und maßgeschneidertes Training zu einem anderen Thema im Bereich Regulatory Affairs interessiert? Oder sind Sie an Unterstützung und praktischen Implementierungsdienstleistungen interessiert?