Training
AKRA TEAM bietet verschiedene Online- und Offsite-Schulungen und Webinare zu ausgewählten Themen im Bereich der regulatorischen, qualitätsbezogenen und klinischen Angelegenheiten an.
Webinare
Monster-Regulierung – Ist sie wirklich so schrecklich aus klinischer Sicht?
Webinar
- 12. März 2025
Ein Leitfaden zu Sufficient Clinical Data
Usability of Medical Devices
Webinar
- Click below for available dates
Regulatory requirements and practical tips
EU and China Clinical Requirements
Webinar
- 25 Feb 2025
How to leverage clinical investigation data for CE marking
Trainings
UKCA - An Introduction
Online Training
- On demand
Detailed overview of the UK MDR, current regulatory landscape and upcoming changes
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
Auditing Clinical Aspects of the MDR
Onsite Training
- Click below for available dates
Auditing Clinical Aspects of EU-MDR and related MDCG Documents
Clinical Evaluation and Clinical Evidence for Medical Devices
Online Seminar/Training
- Click below for available dates
Regulatory requirements and practical tips
SSCPs - An easy approach to be Compliant
Online Seminar/Workshop
- Click below for available dates
Drawing-Up MDR compliant SSCPs: Pitfalls & Solutions
PMS-System under MDR - A structured Overview
Online Training
- Click below for available dates
A structured overview of PMS-PMCF-PSUR
Clinical investigations according to ISO 14155
Online Seminar/Training
- Click below for available dates
Interrelation to EU-MDR & MDCG Guidances
Drug-Device-Combinations - A comprehensive Overview
Online Training
- Click below for available dates
Overview of product categories & regulatory requirements (incl. Article 117)
Literature Search for the Clinical Evaluation
Online Training
- Click below for available dates
Overview, requirements and structured, stepwise approach for SOTA and S&P
MDR compliant QM-Systems
Online Training
- Click below for available dates
Important aspects to avoid pitfalls
High Quality Templates
Check available TD Templates
- Download Area
Benefit from our experience in conformity assessment processes
TD and Riskmanagement
Online Training
- Click below for available dates
Interelation between TD and ISO 14971
MDR Basics
Online Training
- Click below for available dates
Understanding the structure & requirements
Usability of Medical Devices
Webinar
- Click below for available dates
Regulatory requirements and practical tips
Templates
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
Auditing Clinical Aspects of the MDR
Onsite Training
- Click below for available dates
Auditing Clinical Aspects of EU-MDR and related MDCG Documents
Support & Training
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