MyBlueLabel

MyBlueLabel is a SaaS integrated Quality Management solution offered by MyBlueLabel Compliance Services A/S. It aims to simplify, digitalize, and accelerate regulatory compliance processes for companies of all sizes, including medical device manufacturers, pharmaceutical companies, biotechnology companies, clinical research organizations, and healthcare institutions.

Key Features

Fast-track regulatory compliance: According to the vendor, MyBlueLabel offers a digital solution that simplifies and accelerates the compliance journey, potentially allowing companies to become compliant in as little as 5 days, which is claimed to be 30 times faster than traditional implementation methods.

One platform for all compliance processes: MyBlueLabel provides a single platform that supports various compliance processes, eliminating the need for multiple systems or manual processes. The platform includes 16 modules covering different compliance areas, offering a comprehensive solution.

Active dashboards and easy document access: The platform reportedly offers active dashboards with visual data and key metrics for each module, allowing users to track ongoing activities and identify areas requiring action. It is claimed to provide easy access to documents, simplifying document management and ensuring compliance with documentation requirements.

Tailored for compliance requirements: According to the vendor, MyBlueLabel's solution is tailored to meet the specific compliance requirements of each company. It claims to support compliance with various regulations and standards, including FDA, MDR, GDPR, ISO 13485, ISO 9001, ISO 14001, and ISO 27001. Companies can enable individual modules based on their specific needs, ensuring a customized approach to compliance.

Streamlined pre-market activities: MyBlueLabel aims to support pre-market activities such as regulatory approval, ISO certification, audits, clinical trial preparation, supplier management, and risk management. The platform provides a centralized system for managing these activities, potentially simplifying processes and ensuring compliance.

Efficient post-market activities: The platform also aims to support post-market activities such as document management, comprehensive annual reviews, incident management, post-market surveillance, and complaint handling. Companies can potentially manage these activities efficiently, ensuring compliance and timely resolution of issues.

Integration with existing systems: According to the vendor, MyBlueLabel allows for easy integration with existing systems, streamlining compliance processes and ensuring data consistency. Companies can leverage their existing infrastructure while benefiting from the platform's comprehensive compliance features.

Customizable modules: Each module in MyBlueLabel's platform is reportedly customizable, enabling companies to adapt the solution to their specific needs. They can enable or disable modules based on their compliance requirements, ensuring a tailored approach.

Continuous improvement of compliance systems: The platform supports periodic reviews and data analysis, potentially enabling companies to continuously improve their compliance systems. This can help them identify areas for enhancement and ensure ongoing compliance with regulations and standards.