Webinars & Tutorials

Discover a range of free webinars and tutorials from GBA Key2Compliance covering essential topics in regulatory compliance for medical devices, pharmaceuticals, and more. Stay informed with insights from our experts at your convenience. Check out our collection and enhance your knowledge today! Make sure to follow us on LinkedIn for more regular updates.

Webinars
Tutorials

Webinars

LATEST webinarS

IVDR and ISO13485 webinar

How ISO13485 prepares your IVDR Quality System for audits and what it doesn't cover

Presented by: Åse Ek. GBA Key2Compliance 

Tags: IVD, IVDR, ISO 13485, Audit, QMS

Webinar - Why Most Device Start-up Companies Struggle to Survive – Ways to Thrive and Prosper!

Why Most Device Start-up Companies Struggle to Survive – Ways to Thrive and Prosper!

Presented by: Claudia Dannehl GBA Key2Compliance and  Gert Nijenbanning, BAAT Medical

Tags: Regulatory Affairs, Quality Assurance

webinar library

What about Change Management - Webinar

What about Change Management

Presented by: Åsa Möllby, GBA Key2Compliance and Ella Wilhemsson, Medos
Tags: Quality Assurance

Toxicology ISO 10993-17

New edition of the toxicology standard ISO 10993-17:2023 - what has changed?

Presented by: Winta Woldai, GBA Key2Compliance
Tags: Biological Safety

Is your biological evaluation ready for MDR?

Is your biological evaluation ready for MDR?

Presented by: Emma Pedersen and Kristina Fant
Tags: Biological Safety

The new irritation standard ISO 10993-23

The new irritation standard ISO 10993-23 for biological evaluation of medical devices

Presented by: Emma Pedersen
Tags: Biological Safety

The role of GLP in medical device biocompatibility testing

The role of GLP in medical device biocompatibility testing

Presented by: Emma Pedersen
Tags: Biological Safety

Webinar: What about CAPA?

What about CAPA

Presented by: Åsa Möllby, Key2Compliance and Ella Wilhemsson, Medos
Tags: Quality Assurance

Is yourMedical Device Software MDR ready?

Is your medical device software MDR ready?

Presented by: Stina Gustavsson.
Tags: Quality Assurance

Medical Device Software life cycle processes

Medical Device software life cycle processes – IEC 62304 an overview

Presented by: Stina Gustavsson.
Tags: Quality Assurance

Electrical safety IEC 60601

Electrical safety according to IEC 60601

Presented by: Marcus Mellin and Gustav Sundström
Tags: Regulatory Affairs

GMP Re-training

GMP Re-training
How to make it effective!

Presented by: Anna Lundén
Tags: GMP, Training

Tutorials

Medical Devices - From Idea to Market

From idea to market: Introduction

Introduction - Training Contents, and purpose

Part 1: Intended purpose

1. Importance of Intended Purpose. Medical Device, or not?

Part 2: Regulations

2. Regulations - Why do they exist, and how does it impact me?

Part 3: Responsibilities

3. What are the responsibilities of a "legal manufacturer", and how can the Quality Management System support me?

Part 4: Design & Development

4. Processes - part I. Design & Development Process.

Part 5: Software

5. Medical Device Software, definitions, risk classification, and the development process.

Part 6: Processes QMS

6. Process - part II. Quality Management System.

Part 7: PMS and PMCF

7. Post-Market Surveillance (PMS) and PMCF.

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