Training

AKRA TEAM offers various online and offsite trainings and webinars by our experts on selected topics in the field of regulatory, quality and clinical affairs.

Upcoming trainings and webinars

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

 

Usability of Medical Devices

Webinar

Regulatory requirements and practical tips

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

UKCA - An Introduction

Online Training

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

MDR compliant QM-Systems

Online Training

Important aspects to avoid pitfalls

Swiss MedDO

Online Training

Introduction to Swiss MedDO

TD and Riskmanagement

Online Training

Interelation between TD and ISO 14971

MDR Basics

Online Training

Understanding the structure & requirements

Auditing Clinical Aspects of the MDR

Onsite Training

Auditing Clinical Aspects of EU-MDR and related MDCG Documents

Support & Training

You have not found the right training for you and you would be interested in an offer for a specific and customized training on another topic in the field of regulatory affairs? Or you are interested in support and hands on implementation services?

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