"Together we will find a pragmatic approach with regulatory requirements for medical devices"

Health Institutions

How do we deal with the Medical Device Regulation (MDR)?

Can we use the in-house rule in MDR Aticle 5(5)?

When is software a medical device?

What about  AI?


When is software a medical device?

How do we deal with the Medical Device Regulation (MDR)?

How do we claim compliance with MDR?

What about AI software?

Quality Management System

What are the requiremements for a Quality Management System?

How do we shape the Quality Management System?

How do we adapt to the product risk level?

Is it possible to be pragmatic?

Get help

Determing if the product is a medical device

Define the regulatory requirements for the specific product

Make a regulatory strategy in a pragmatic way

Make it clear how the regulatory requiremens influence the development and maintenance of the product

How to work agile with the software development when being a medical device

CE marking in Europe

FDA clearance in USA

MDR article 5(5) compliance for health institutions

I am a Regulatory Expert within Medical Devices with extended knowledge within digital health solutions like apps and software for telemedicine, mobile health, telehealth, AI etc. This goes for CE-marking within EU and FDA 510(k) clearance in USA.

I have gained experience with a pragmatic approach to the regulatory requirements, which is essential when defining a regulatory strategy that is needs-driven, market-driven and competitive. 

In the same way I have several years experience consulting within regulatory challenges in relation to digitization of healtcare systems.

I have been involved in implementation and improvement of cetified quality management systems according to ISO 13485 and FDA 21CFR820. This applies in both small and large organisations in connection with development, production and delivery of physical medical devices, software, and apps.

The many years of experience as a development manager, project manager and not at least as a consultant in the development of medical devices are of great importance to the strategies and proposed solutions that I bring to the table.

Niels Ole Andersen

Tel: +45 40582666


noaQA ApS

Anton Bast Vej 5

DK-9480 Loekken


CVR/VAT:  DK39644576

Niels Ole Andersen