Manufacturing Solutions
Medical Devices LIMS
Medical device laboratories need a LIMS that supports their contributions to patient safety, manufacturing efficiency and business productivity.
Improve Lab Operations with ELab LIMS for Medical Devices
Medical device manufacturers rely on laboratory testing to ensure their products meet exacting manufacturing quality standards such as 21 CFR Part 820 and ISO 13485. This testing covers all aspects of the manufacturing process from raw material acceptance to environmental monitoring to biocompatibility. Whether these are the responsibilities of a single lab or multiple departments, all testing results must be accessible by stakeholders throughout the organization. These reasons and more make a flexible, scalable LIMS essential for any medical device testing laboratory.
LabLynx configures ELab LIMS for Medical Devices with everything your lab needs to support your company’s quality, safety and business goals. Our modular LIMS platform scales to meet the needs of testing operations at any scale. As the central source of truth for your lab’s testing activities, ELab LIMS improves data sharing within your lab and with the rest of the organization. At the same time, ELab LIMS for Medical Devices makes laboratory operations more efficient and better able to meet ISO 17025, ASCA and other laboratory standards.
Configured for the Needs of Medical Device Laboratories
Sample Management & Tracking
ELab LIMS helps you plan and schedule sample collection. Auditable tracking systems follow samples from the point of collection.
Configurable Methods & Workflows
Without any coding, your staff can modify or add methods to quickly respond to changes in the manufacturing process or new business requirements.
Instrument Integration
Eliminate error-prone manual setups and data transfers by integrating your instruments with ELab LIMS. Improve up-time by planning maintenance and calibration events.
Secure Access Control
Defining access permissions by each user’s role, certifications, location and department improves security while keeping your lab aligned with best practices.
Lot & Batch Management
Associate each sample by lot or batch number to improve traceability and speed the identification of potential quality issues.
Customizable Reports
Report-building tools let you create customized COAs and other reports that automatically draw data directly from ELab LIMS.
System Integration
Link your LIMS with your enterprise’s production quality management and other systems to make testing data more accessible to stakeholders.
Streamlined Accreditation & Compliance
Automation, record keeping, documentation storage and other features help your lab achieve and maintain ISO/IEC 17025 accreditation while conforming to regulatory guidance.