MyBlueLabel - Setting New Global Standards

Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated into your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.

ISO
DNV-GL ISO 9001
Microsoft Azure

A Selection of Companies Who Trust Us

Nordic Eye
Vulcur MedTech
June
Sonohaler
Plura

Our Modules

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Inventory Management

Inventory Management provides you with an overview of the technical landscape in the entire company.
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Project Management

Project Management helps you organize your project portfolio based on predefined project plan templates.
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Document Management

Document Management gives you and your team the timesaving possibility to create, edit and store all the project documents.
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We collaborate with extraordinary organizations

Symbion
Cobis
Upgraded
Accelerace
Medico
MedTechBridge
DTU

Testimonials

We signed the last procedure after just 4 days – it is absolutely incredible!

It has been a pleasure to work with the MBL platform and QMS! Kenn and his team provided interesting knowledge in a welcoming way, which has given us a clear understanding of QMS and its significance for our company. MyBlueLabel writes that they can establish a QMS in 14 days, but we signed the last procedure after just 4 days – it is absolutely incredible. Other comparable companies have paid 600,000 DDK and can not yet explain the importance of a QMS. MyBlueLabel helped us get started and we continued to use the IT solution smoothly. We feel safe using the system and can say with great conviction that MyBlueLabel delivers a high quality product for a low monthly performance and pay-as-you-grow solution so everyone can join

Victor Staalkjær & Andreas Tuxen

Co-founders, June Systems

An Intuitive System

Providing support to more than 100 life science student startups, we’re delighted to collaborate with MyBlueLabel. Their Quality Management System software for Medical Device complies with both FDA and EU Regulation and the combination of dedicated support from the MyBlueLabel and an intuitive system makes compliance both time efficient and inexpensive for our members

Peter Løvschall

Innovation Consultant, University of Copenhagen, Faculty and Health and Medical Sciences

MyBluelabel makes sure that I am comfortable with Regulatory Compliance and I understand what is relevant for our product!

Back in March 2020, I was introduced to MyBlueLabel through a renowned Danish start-up environment. Thanks to MyBlueLabel, I now have an ISO 13485 QMS ready for audit for a fraction of the cost and in just 5 days. I also have an IT-system that guides the implementation of the ISO 13485 and the Technical File. To me, the best thing is that MyBluelabel makes sure that I am comfortable with Regulatory Compliance and I understand what is relevant for our product!

Khanhvi Tran

Co-Founder & CTO, Sonohaler

Big advantage

VulCur MedTech develops medical devices for the American and European market. It is therefore necessary for us to have an ISO certified Quality Management System. We are a start-up and became eligible for an offer, which included a Quality Management System and templates. This made an enormous difference in terms of economy and time. We reaped the benefits of MyBlueLabel and estimated savings of 70.000 – 100.000 DKK. In addition, the system has given us help of direction. In summary, the system has provided a big advantage and experience – we could not imagine our business without it.

Janus Beierholm

CEO, VulCur MedTech

Ensures full transparency, traceability and change management

MyBlueLabel have built a platform based on the Plan-Do-Check-Act approach, which makes it possible to implement a Management System that handles quality, work environment, responsibility or information security. The MyBlueLabel platform ensures full transparency, traceability and change management when dealing with a company’s processes and relevant documentation

Marianne de Montis

Lead Auditor, Management System Certification, DNV GL Business Assurance

I can see direct relevance for so many Medical technology centric companies

 I had the pleasure of meeting the team behind MyBlueLabel. Their platform cuts through the complexity of MedTech and Digital Health regulation by offering a cloud-based solution to companies that sees Quality as a top priority. I strongly recommend this platform to companies under my program at DTU Entrepreneurship for the speed of implementation, the functionality and the commitment to help them grow.  I can see direct relevance for so many Medical technology centric companies, run by engineering who have very little idea of the procedure to meet ISO compliance. MyBlueLabel seems to be a very well-suited solution.

Thomas J. Howard

Head of X-Tech & Impact Lab, DTU Entrepreneurship  

All gathered in one place

MyBlueLabel have given us a collaboration platform and communication flow, where we are in control of the dialogue threads and latest version of our documents – all gathered in one place. MyBlueLabel makes sure that we work effectively and have provided us with full transparency in the organization

Anne-Marie Hall Henriksen

CEO & Founder, Amazing Hall

High level of efficiency

Nordic Eye has used MyBlueLabel’s Deal Base for managing deal flow and ongoing communication with potential investment cases. It is an essential tool for Nordic Eye as it helps us structure our work efforts and manage our resources. With MyBlueLabel’s Deal Base we ensure a high level of efficiency in the investment process and we are able to track all cases from first point of contact. Deal Base makes sure that we handle all inquiries in the best possible way, and ultimately, it gives us the best basis for decision-making.

Joakim Warnøe

Partner & Head of Portfolio Analysis, Nordic Eye