Biological Safety Consulting
Ensuring Patient Safety with Biological Safety Expertise
At GBA Group, we prioritize patient safety by offering comprehensive biological evaluations for all medical devices. Our team of experienced toxicologists excels in planning, performing, and documenting these evaluations, ensuring compliance with the latest standards and regulations.
Comprehensive Services for Medical Device Compliance:
Biological Evaluation and Risk Assessment
- Creation of Biological Evaluation Plans (BEP) and Reports (BER)
- Conducting GAP-analysis and toxicological risk assessments
- Systematic literature reviews
Compliance and Standards Analysis
- MDR, and global guidelines
- Developing Standard Operating Procedures
Testing Coordination
- vivo studies
- Management of transportation, packaging, stability, and cleaning validation
Toxicology Services
- Expertise in evaluating medical devices, chemicals, and cosmetics
Quality Assurance Support
- Assistance with Good Laboratory Practice (GLP) queries
Training and Education
- Customized and public training sessions on biological evaluation
On-Demand Biocompatibility Expertise
For start-ups and smaller manufacturers, we offer expert biocompatibility services on demand. Our team has extensive experience with all classes of medical devices and combination products, ensuring compliance with MDR and REACH regulations. We stay current with regulatory requirements and participate in standardization work through ISO TC 194.
Advancing Alternatives to Animal Testing
Committed to reducing animal testing, GBA Group advises clients on in vitro methods. Our team’s experience with various test methods ensures cost-effective and compliant biological evaluations.
Quality Assurance and Laboratory Expertise
Our team is well-versed in GLP, ISO 17025, and ISO 15789 standards. We assist in laboratory selection, study design, and test report reviews, ensuring compliance with quality management systems. Kristina Fant, our Director of Biological Safety, is a renowned expert and co-author of the OECD guidance document GIVIMP.
Rely on our experts
“We believe in a team effort for biological evaluations, sharing our in-depth knowledge in toxicology, materials science, manufacturing, and clinical use to benefit our clients and ultimately the patients.”
Kristina Fant, Director of Biological Safety
GBA Key2Compliance
To discover more about how we can support your biological safety needs beyond what you've read here, visit the GBA Key2Complience website. Explore our extensive range of services, expertise, and resources tailored to ensure the safety and compliance of your medical devices. Join our community of satisfied clients and experience the benefits of working with industry-leading experts.