How LabHQ LIMS streamlines Medical Device development and quality control
LabHQ enhances efficiency, safety, and compliance in medical device development and quality control.
Navigating hurdles in the Medical Device industry
Medical device labs face tough challenges, from ensuring product safety to meeting global standards, all while managing a mountain of documentation.
What LabHQ provides for Medical Device companies
LabHQ delivers top-notch solutions to keep you compliant, guarantee product quality, and streamline development in the medical device world.
Sample tracking
Keep tabs on samples from start to finish– from submission to approval and certificate generation. Store all data digitally and reduce error-prone manual data entry.
Custom fields
Capture unique data points and define custom data fields beyond the standard LabHQ options. Add, modify, or remove fields as needed to match your lab's evolving needs.
Version Control, Audit and Encryption
Maintain data integrity with complete version histories, tracking changes, timestamps, and user actions. Ensure traceability and compliance with regulatory standards. Keep data secure with encryption at rest and in transit, and link records to responsible users with electronic signatures.
Certificate of analysis
Generate sample certificates at the click of a button. Reduce manual error, speed up turnaround times, and tailor certificate templates to meet client-specific needs, effortlessly. Stay compliant with FDA, GMP, and ISO standards.
We are often inspected by FDA and MHRA to GMP regulations and by UKAS to maintain and continuously develop our schedule of accreditation. LabHQ facilitates our adherence to data integrity regulatory standards such as FDA 21 CFR Part 11 and ISO 17025
LabHQ solutions for Medical Device development & quality control
LabHQ delivers tailored solutions to streamline processes, enhance reporting, and ensure compliance in medical device development.
Enhanced Testing
Improves product reliability through rigorous testing protocols.
Quality Control
Ensures consistent product quality and safety.
Documentation Efficiency
Streamlines documentation and reporting processes.
Regulatory Compliance
Automate compliance with FDA, CE marking, and ISO 13485 standards.
Performance Verification
Conduct thorough performance and durability testing to ensure device reliability.
Data Management
Securely manage extensive documentation and traceability requirements.
Security and compliance in our DNA
Built for quality, compliance, and peace of mind by a team with decades of QC and GxP experience in highly regulated industries.
FDA 21 CFR Part 11
Stay compliant with FDA 21 CFR Part 11 for secure, trackable electronic records and signatures.
GMP & GLP
Adhere to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to ensure safe products through strong quality control (QC), clear documentation, and consistent, reliable non-clinical lab data.
MHRA
Meet MHRA guidelines and protect patient data with HIPAA compliance for data safety.
HPRA
Stick to Health Products Regulatory Authority (HPRA) standards for quality and safety in lab testing.
ISO 17025
Get ISO 17025 certified with validated testing methods and accurate, traceable lab results.
ISO 9001
Maintain ISO 9001 standards for quality management systems ensuring consistent, high-quality outputs.
FAQs
What is a Medical Device LIMS?
A Medical Device LIMS manages data and processes in medical device testing and development labs.
What are the benefits of using a Medical Device LIMS?
Benefits include improved compliance, consistent product quality, and streamlined workflows.
Does LabHQ integrate with design & engineering software?
LabHQ integrates seamlessly with other software used in medical device development.
Is LabHQ secure?
Yes, LabHQ offers robust security features to protect sensitive data.
