培训
AKRA TEAM提供各种在线和离线培训以及网络研讨会，由我们的专家就法规、质量和临床事务领域的特定主题进行讲解。
即将举行的培训和网络研讨会
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