Looking to achieve ISO 15189, GxP, IVDR, or CLIA certification? 

• Mobiolink is a middleware software designed for the management and technical support of laboratory processes.
  Mobiolink solely performs mathematical calculations and data processing functions based on parameters defined by the user.

• All threshold values, calculation parameters, and evaluation algorithms are specified, validated, and approved by qualified personnel of the user organization.

• Mobiolink does not make any independent clinical diagnoses or medical decisions and does not replace professional interpretation by qualified medical personnel.

• Responsibility for the correct parameterization, validation of the applied algorithms, and the clinical interpretation and release of results lies entirely with the user.

• Mobiolink is not an independent in vitro diagnostic medical device as defined by Regulation (EU) 2017/746 (IVDR) or other applicable medical device regulations.

Mobiolink is strategically designed as an administrative software tailored for specialized laboratories and explicitly developed as a non-medical device. This deliberate approach offers substantial advantages for customers, notably:

1. Greater Flexibility and Rapid Development:

By not requiring certification as a medical device, Mobiolink can significantly accelerate software development and deployment cycles. This flexibility allows continuous improvements, updates, and innovative features to be released more frequently, keeping the software responsive to evolving laboratory needs.

2. Reduced Regulatory Burden and Cost Savings:

Medical devices must adhere to strict regulatory processes and compliance standards, often demanding considerable time, financial resources, and documentation. By avoiding classification as a medical device, Mobiolink reduces overhead costs and administrative efforts, allowing resources to be redirected towards enhancing functionality and customer-oriented innovation.

3. Customization and Agility:

Without certification constraints, Mobiolink has greater scope for customization. Customers benefit from tailored software solutions quickly adapted to specific laboratory processes or unique operational requirements. This agility ensures the software precisely matches customer workflows without delays typically associated with certified medical software adjustments.

4. Simplified Updates and Maintenance:

Non-certified software enables quicker, more straightforward software updates and maintenance. Customers can seamlessly implement updates without prolonged validation and regulatory approval phases, ensuring laboratories continually operate using up-to-date and secure technology.

5. Faster Responsiveness to Customer Needs:

Being outside the stringent framework of medical device certification allows Mobiolink to respond rapidly and dynamically to customer feedback, regulatory shifts, market demands, and technological advancements. Laboratories thus benefit from immediate feature improvements, solving practical problems efficiently and effectively.

6. Complete Freedom in Supplier and Instrument Selection:

Since Mobiolink is not classified as a medical device, laboratories maintain full independence in choosing their assay and instrument suppliers. Customers can freely select the most suitable partners based on performance, cost-efficiency, or specific technical criteria, without any software-related limitations or vendor lock-in.

7. Unrestricted Development of Laboratory Developed Tests (LDTs):

Customers benefit greatly from Mobiolink's non-medical device status as it imposes no constraints on the development, validation, or implementation of Laboratory Developed Tests (LDTs). Laboratories thus retain full flexibility to innovate and optimize their testing methodologies to precisely match clinical or research needs without facing regulatory or software-induced restrictions.