MyBlueLabel enables Life Science Companies to reduce time-to-market

MyBlueLabel has the solution for Quality Management Systems within Pharma, Biotech, and Medtech Industries to optimize and maintain business critical tasks to go-to-market. Never worry about regulatory approvals, ISO certifications or audits again.

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30 x Faster Implementation
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Support through all regulatory processes
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Total compliance services offering
Testimonials

Our mission is to provide a user friendly platform, including high quality services, implemented instantly to provide immediate value

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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
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
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
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, MS Certification, DNV GL Business Assurance
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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, MS Certification, DNV GL Business Assurance
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
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
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
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

Selection of companies who trust us

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Best-practice IT-system and value-added consultancy services

The very foundations of MyBlueLabel were built on the principle to meet the needs of both bigger and smaller companies because they must fulfill the same MDD, MDR, FDA and ISO requirements – we treat every organization with respect regardless of its size.

We collaborate with extraordinary organizations

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Modules in MyBlueLabel QMS Software

MyBlueLabel has a suite of modules to support the full ecosystem of processes to comply with regulations and international standards. The modules are integrated or can work as standalone modules.