Building Medical Device Innovations Together
Client Ask: “(what was Axoltol’s need) “
Client: Bioprinting for tissue engineering and regenerative medicine
Initial Service Areas Identified:
Client Ask: “(what was Axoltol’s need) “
Client: Bioprinting for tissue engineering and regenerative medicine
Initial Service Areas Identified:
“Client Quote/Testimonial”
How We Partnered
- Regulatory landscape and strategy
- Internal audits
- Q-submissions and FDA interaction
- Clinical study IDE, IND applications
- 510(k), De Novo, PMA, BLA
- Breakthrough or RMAT designation
- Quality systems, SOPs, MDSAP
- MDR Gap analysis and strategy
- PMS and PMCF procedures
- CE Mark
- Technical files
- Clinical Evaluation Reports (CERs)
Services Provided as a Result of Our Integrated Approach
- Regulatory & Quality Services 100%
- Evidence Services 65%
- Clinical Research Services 80%
Client Successes & Results of Partnering with Telos
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Bonus Outcomes & Competitive Advantage Gained
Main Bonus Outcome here
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