Contact

Instructor

Åse Ek

Åse Ek is employed at GBA Key2Compliance and has more than 20 years of experience in the Medical Device and Pharmaceutical industries. Åse has worked with product development, project management and quality and regulatory issues. In recent years, especially with QA / RA in post market surveillance and issues related to public procurement, marketing, and distribution.

Åse’s role at GBA Key2Compliance include training and consulting in quality assurance and management systems according to ISO 13485 and regulatory matters.

Related courses to Åse Ek

Change Management for Medical Devices

How to apply a risk-based approach when managing changes to your medical device to ensure compliance, maintain quality, and ultimately protect patient safety.
May 15
Online
Change management, Risk

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.
Apr 29
- Apr 30, 2025
Copenhagen, Denmark
Post market, Quality management and QA, Regulatory Affairs

Sterilization of Medical Devices

In-depth training on assessing suitability, adequacy and effectiveness of medical device sterilization methods.
Auditing/Inspection, Bioburden, ISO 11737, Sterilization, Validation

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.
Nov 19
- Nov 20, 2025
Copenhagen, Denmark
Quality management and QA

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

Roadmap to Market Step 6 – Post-Market Surveillance

Training to get insight in Medical Device Post-Market Surveillance, a systematic process to collect and utilize experience on devices in use, in the field.
On demand
Medical devices, Post market

Will 21CFR820 be fully replaced by ISO 13485?

Online
Quality management and QA

IVDR in a nutshell – Risk Management

What is required to demonstrate compliance to the IVDR regarding Risk Management? How do I perform risk analysis, and estimate probability and severity? How to deal with legacy devices? This training will give you the answers!
Online
In-vitro Diagnostics, Risk

IVDR in a nutshell – Technical Documentation

What is required from your technical documentation to achieve CE-certificate for your in-vitro diagnostic devices? This training will give you the answers!
Online
In-vitro Diagnostics

IVDR and requirements on the Quality Management System

- What are the requirements on legal manufacturers, to achieve CE-certification for in-vitro diagnostic devices? - What will the NB need look for when auditing our Quality Management System? - What is the responsibility of the PRRC, in relation to the QMS? This training will give you the answers!
Jun 18
Online
In-vitro Diagnostics, Quality management and QA

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.
Jun 3
Online
Auditing/Inspection, Quality management and QA

MDR Audit Readiness

MDR Audit Readiness – how to assess if your ISO 13485:2016 Quality Management System is MDR compliant
Online
Auditing/Inspection, Quality management and QA

Search

Search