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.
Webinars
Usability of Medical Devices
Webinar
- Click below for available dates
Regulatory requirements and practical tips
Monster-Regulierung – Ist sie wirklich so schrecklich aus klinischer Sicht?
Webinar
- 12. März 2025
Ein Leitfaden zu Sufficient Clinical Data
EU and China Clinical Requirements
Webinar
- 25 Feb 2025
How to leverage clinical investigation data for CE marking
Trainings
UKCA - An Introduction
Online Training
- Click below for available dates
Detailed overview of the UK MDR, current regulatory landscape and upcoming changes
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
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
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
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?