Inventory
Project
Configuration
Incident
Change
CAPA
Knowledge
TestGet rid of uncertainties – Fast track your regulatory compliance
Choosing MyBlueLabel gives you the comfort of a smooth regulatory process, reduced resources spent, and faster product launch in EU and USA. MyBlueLabel is developed by industry experts.
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.
30 x Faster Implementation
Support through all regulatory processes
Total compliance services offering
Our mission is to provide a user friendly platform, including high quality services, implemented instantly to provide immediate value
Read moreVulCur 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.
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.
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
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
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
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
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.
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!
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
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.
Selection of companies who trust us
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
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.
Inventory
Inventory Management provides you with an overview of the technical landscape in the entire company.
Document
Document Management gives you and your team the timesaving possibility to create, edit and store all the project documents.
Project
Project Management helps you organize your project portfolio based on predefined project plan templates.
Configuration
Configuration Management provides controlled version of the Code and Configuration of the system.
Incident
Incident Management serves as support to your hotline or helpdesk. Categorizing the incident helps trending on issues.
Change
Change Management gives you and your team the possibility to see all changes made during projects and operations.
Deviation
Deviation Management provides the functionality to create, track, monitor, and close deviations for IT systems.
CAPA
CAPA Management provides you with the template to assign actions to individuals needing to close out the Deviation.
Knowledge
Knowledge Management brings shared information and “lessons learned” into the organization with ease.
Training
Training Management provides the possibility to assign training based on organization and roles. It tracks the training completion progress throughout the company.
Test
Test Management gives you and your team the possibility to author, review, approve and execute testing activities electronically and instantly.
Complaint
Complaint Management enables registration and tracking of customer complaints for timely communication to ensure customer satisfaction.