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。
网络研讨会

EU and China Clinical Requirements
Webinar
- 25 Feb 2025
How to leverage clinical investigation data for CE marking

Usability of Medical Devices
Webinar
- Click below for available dates
Regulatory requirements and practical tips

PMS-System under MDR - A structured Overview
Online Training
- Click below for available dates
A structured overview of PMS-PMCF-PSUR
培训活动

UKCA - An Introduction
Online Training
- Click below for available dates
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
模板

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