Non-Clinical
& Pre-Clinical
Consulting Services
Technical and Regulatory Knowledge for Targeted Testing Strategy at Each Step of the Regulatory Pathway
CardioMed consultants and a curated network of specialists provide expert advice on all aspects of engineering, non-clinical testing, and pre-clinical studies integrated in cardiovascular device development. Coupling science and engineering expertise with vast experience of regulatory expectations helps optimize device design, design appropriate non-clinical tests, and evaluate the necessary endpoints that will save time and money.
End-to-End Pre-Clinical
Testing & Strategy
- Principal Consultants with direct industry and/or government regulatory experience
- Perform medical device design review
- Correlate technical features with safety and effectiveness risks
- Familiarity with a variety of devices and technologies across cardiovascular device space
- Scientific advice related to design and development of combination products
- Develop pre-market testing strategies to meet regulatory goals and expectations
- Identify necessary testing based on engineering principles and regulatory precedents
- Recommend test methods and endpoints to mitigate risks sufficiently
- Assist with data analysis and test report drafting
- Biocompatibility safety assessment
- Chemical characterization and Toxicological Risk Assessment (TRA)
- In Vivo animal study protocol development
- Acute vs. Chronic animal studies
- GLP and Non-GLP animal studies
- Packaging testing requirements for IDE and marketing application
- Software, cybersecurity, interoperability, and EMC considerations
- Sterilization, viral inactivation, and reprocessing validations
- Computational FEA, fatigue testing, and durability testing of permanent implant devices
- Device failure analysis and corrective action development
- Expert witness services in patent infringement and product liability cases
Trusted Networks
Subject Matter Experts & Test Laboratories
CardioMed maintains a network of subject matter experts (SMEs) well-established in the medical device field, to support all aspects of non-clinical and pre-clinical testing — including high-cost, long-lead testing such as software/cybersecurity, implant durability, biocompatibility, and chemical characterization. To meet client needs, we connect clients with high-quality, reliable test laboratories to generate timely and cost-effective results to support short-term and long-term regulatory goals.
The CardioMed Difference
Combined knowledge of scientific and engineering principles alongside FDA expectations at each phase of the regulatory pathway.
Access to a network of well-established subject matter experts across specialized cardiovascular device testing disciplines.
Established relationships with reputable test laboratories for cost-effective, timely, and reliable pre-clinical testing results.
Prospective approach to ensure non-clinical and pre-clinical testing seamlessly supports clinical study initiation and regulatory timelines.
Ready to Optimize Your
Pre-Clinical Strategy?
Connect with CardioMed to build an efficient, regulatory-aligned pre-clinical testing program for your device.
Schedule a Consultation