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GBA Key2Compliance solves all your training needs in terms of regulatory requirements, GMP, GXP and quality systems. Knowledge of these requirements is an important key to developing, manufacturing and distributing safe and effective drugs and medical devices. Training from GBA Key2Compliance makes the knowledge easily accessible, applicable and makes it clear how the regulatory requirements affect your business.

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GMP MasterClass

Get a comprehensive review of GMP compliance requirements and tools to master application and interpretation of these requirements in pharmaceutical production.
QC-lab, Quality management and QA

Design, Development and Regulatory Compliance for Medical Devices and SaMD

Learn how to apply design controls to ensure regulatory compliance for both hardware and software medical devices using agile development principles. This course covers ISO 13485, IEC 62304, EU MDR, FDA, risk management, SaMD, AI, and cloud-based technologies.
ISO13485, IVDR, MDR, Regulatory Compliance

Validation of Analytical Procedures Made Easy

What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality? This webinar is focused on a “Faster, Better, Cheaper” methodology. Targeted to medical device and pharmaceutical professionals involved in meeting Design Control and Process Validation.
Online
Design Control, Statistics, Validation and Qualification

Usability for Medical Devices

How do you know if the users think your device is “Easy to use”? Learn how to establish, implement and monitor a usability process.
Jun 24
Online
Usability

Cybersecurity in Medical Device Lifecycle

How to have your Medical Devices compliant with the cybersecurity requirements: risk management, design, development, maintenance, and post-market surveillance.
Online
Computers/Software

Introduction to IVDR – Fundamentals of IVDR and CE-marking of IVDs

Learn about the IVDR and CE-marking of IVD medical devices. Understand the regulatory requirements for IVD medical devices. Understand the obligations under IVDR
Online
IVD, IVDR, Regulatory Compliance

Responsibilities of the PRRC – and methods to manage them

Get understanding of the responsibilities of the PRRC and how this can be defined within the organisation. Important also for CEO and top management.
Online
IVDR, MDR, Quality management and QA, Regulatory Affairs

ISO13485:2016 – from an auditing perspective

Get a full understanding of the requirements ISO13485:2016 place on your Quality Management System, as well as the solutions recommended in the 13485 Handbook.
Online
Auditing/Inspection, Quality management and QA

Advanced Training in Biological Evaluation of Medical Devices

Learn how and when a biological evaluation, according to ISO 10993-1, should be performed. Understand the evaluation requirements and avoid common pitfalls!
May 19
Mölndal-Gothenburg, Sweden
Biocompatibility

Design of Experiments – DOE

What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality?
May 25
Online
Design Control, Statistics, Validation and Qualification

CE-marking – Risk classification of IVDs & Technical Documentation

Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route Learn about the general safety and performance requirements and how to demonstrate compliance Understand the structure and content of the Technical Documentation Understand how design changes to the product design impact on the technical documentation
Online
CE-marking, Documentation, IVD, IVDR, Risk

Process validation – Medical Devices

Gain increased knowledge about both the preparations required and the main parts that are included in process validation for medical devices.
Apr 14
Online
Validation and Qualification

Are Your Data Normal or Not?

What is “Normal” data? How do you know if your data are Normal? What do you do if your data are not Normal? Why would you care?
Online
Statistics

IVDR Performance Evaluation, Risk Management, PMS and PMPF

Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route Learn about the general safety and performance requirements and how to demonstrate compliance Understand the structure and content of the Technical Documentation Understand how design changes to the product design impact on the technical documentation
Online
CE-marking, IVDR, Post market, Risk

Medical Device Supplier Control and Outsourcing

Get tools and examples of best practice and learn how use the ‘Plan – Do – Check - Act approach’ to control and verify the performance of your suppliers.
Quality management and QA

Becoming a Regulatory Affairs Manager for Medical Devices

Get the knowledge and skills needed to lead the RA function at a medical device organization. Interpret and apply MDR, IVDR, and ISO 13485 effectively.
May 6
- May 7, 2026
Copenhagen, Denmark
Post market, Quality management and QA, Regulatory Affairs

ISO 14155:2020 – Good Clinical Practice for Medical Devices (GCP)

A practical approach to medical device clinical investigations according to ISO14155. How to plan, perform and document. Examples on what to focus on and which types of investigations to apply when, during your device development.
Apr 28
- Apr 29, 2026
Online
Clinical development, Clinical investigations

IVDR training series: Mastering IVDR Compliance

Training series contains 3 parts, half a day each.
  1. Intro to IVDR -Fundamentals of the IVDR and CE-marking of IVDs
  2. CE-marking - Risk classification of IVDs and Technical Documentation
  3. IVDR Performance Evaluation, Risk Management, PMS and PMPF
- Feb 5, 2026
Online
CE-marking, IVD, IVDR, Post market, Risk

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