Training

AKRA TEAM bietet verschiedene Online- und Offsite-Schulungen und Webinare zu ausgewählten Themen im Bereich der regulatorischen, qualitätsbezogenen und klinischen Angelegenheiten an.

Webinare

EU and China Clinical Requirements

Webinar

How to leverage clinical investigation data for CE marking

Usability of Medical Devices

Webinar

Regulatory requirements and practical tips

PMS-System under MDR - A structured Overview

Online Training

A structured overview of PMS-PMCF-PSUR

Trainings

UKCA - An Introduction

Online Training

Detailed overview of the UK MDR, current regulatory landscape and upcoming changes

Joint Onsite-Workshop on
Drug-Device-Combinations

Onsite in Munich

How to successfully navigate the Drug-Device Combination Products Landscape

Auditing Clinical Aspects of the MDR

Onsite Training

Auditing Clinical Aspects of EU-MDR and related MDCG Documents

Clinical Evaluation and Clinical Evidence for Medical Devices

Online Seminar/Training

Regulatory requirements and practical tips

SSCPs - An easy approach to be Compliant

Online Seminar/Workshop

Drawing-Up MDR compliant SSCPs: Pitfalls & Solutions

PMS-System under MDR - A structured Overview

Online Training

A structured overview of PMS-PMCF-PSUR

Clinical investigations according to ISO 14155

Online Seminar/Training

Interrelation to EU-MDR & MDCG Guidances

Drug-Device-Combinations - A comprehensive Overview

Online Training

Overview of product categories & regulatory requirements (incl. Article 117)

Literature Search for the Clinical Evaluation

Online Training

Overview, requirements and structured, stepwise approach for SOTA and S&P

MDR compliant QM-Systems

Online Training

Important aspects to avoid pitfalls

Swiss MedDO

Online Training

Introduction to Swiss MedDO

High Quality Templates

Check available TD Templates

Benefit from our experience in conformity assessment processes

TD and Riskmanagement

Online Training

Interelation between TD and ISO 14971

MDR Basics

Online Training

Understanding the structure & requirements

Usability of Medical Devices

Webinar

Regulatory requirements and practical tips

Templates

High Quality Templates

Check available TD Templates

Benefit from our experience in conformity assessment processes

Joint Onsite-Workshop on
Drug-Device-Combinations

Onsite in Munich

How to successfully navigate the Drug-Device Combination Products Landscape

Auditing Clinical Aspects of the MDR

Onsite Training

Auditing Clinical Aspects of EU-MDR and related MDCG Documents

Support & Training

Sie haben nicht das richtige Training für sich gefunden und wären 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?

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