Ajit P. Yoganathan, PhD
Principal Consultant
Dr. Ajit Yoganathan is a Principal Consultant at CardioMed Device Consultants and an internationally recognized leader in cardiovascular engineering, biomechanics, and medical…
Read bio →Preclinical Testing Consulting
The right testing strategy at each step of your regulatory pathway.
CMDC’s preclinical experts help you build the evidence your device needs to reach the market, from in vitro bench testing to in vivo animal studies. From your first test plan to a final review before submission, we make sure your testing answers the questions FDA will ask, without unnecessary work or late surprises.
How we can help
STARTING OUT
Plan your test program
We build a preclinical test plan matched to your device's risks and regulatory pathway, from in vitro bench testing to in vivo animal studies.
TESTING UNDER WAY
Review your protocols and reports
We review your protocols, test reports and data, and flag gaps while there's still time to fix them.
PREPARING TO SUBMIT
Get expert feedback before you submit
We assess whether your preclinical evidence gives FDA a complete, convincing picture before it reaches a reviewer.
Why CMDC
Why clients choose CMDC.
Experts in a most testing disciplines
From in vitro bench testing and biocompatibility to toxicology, in vivo animal studies, electrical safety, software and cybersecurity, each area is covered by a specialist.
Testing tied to what FDA expects
We connect your device's risks to the evidence FDA will want to see, and plan testing around your clinical and submission milestones.
The right specialists and labs
When your program needs testing support, we connect you with experienced specialists and laboratories that fit your device, budget and timeline.
Our Capabilities
What our subject matter experts do for you.
Test strategy and planning
A preclinical test plan built around your device's risks and your regulatory goals.
- Device and risk review across engineering, biological, electrical and software risks
- Test plans based on scientific principles and regulatory precedent
- Test method and endpoint recommendations
- Scientific advice on combination products
In vitro bench testing
The performance, durability and reliability evidence behind your device.
- Performance and mechanical testing
- FEA, fatigue and durability testing of permanent implants
- Packaging and sterilization validation
- Failure analysis and corrective actions
Biocompatibility, chemistry and toxicology
Biological safety evidence that meets current FDA expectations.
- Biocompatibility safety assessment
- Chemical characterization
- Toxicology and toxicological risk assessment
- Biological evaluation plans and reports (ISO 10993)
- Led by Chiara Lorenzetto, a biological safety specialist with nearly 20 years of experience.
In vivo animal studies
Animal studies designed to answer the right questions the first time.
- Study design and protocol development
- Acute and chronic studies
- GLP and non-GLP studies
- Animal model selection
- Endpoint selection and results review
- Led by Lynn Bailey, who has directed hundreds of regulatory preclinical studies over 35+ years.
Electrical safety, software and cybersecurity
Expertise for powered, connected and software-driven devices.
- Medical electrical safety
- EMC and interoperability
- Software verification and validation
- Cybersecurity risk assessments and FDA cybersecurity documentation
- MR compatibility
Review and expert feedback
A second set of expert eyes on testing you've already done or planned.
- Review of protocols, test reports and data
- Gap assessment before submission
- Data analysis and test report support
- Expert witness services
TESTING AREAS WE ADVISE ON
From in vitro bench testing to in vivo studies.
Not sure which tests your device needs? That's often the first question we answer.
- Design review
- In vitro bench testing
- Biocompatibility
- Chemical characterization
- Toxicology and toxicological risk assessment
- In vivo animal studies (GLP and non-GLP)
- Packaging
- Sterilization
- Medical electrical safety
- Software V&V
- Cybersecurity
- EMC and interoperability
- MR compatibility
- FEA
- Fatigue and durability
- Failure analysis
- Combination products
Trusted network
Specialists and laboratories when your program needs them.
Some testing is costly and slow to arrange, from software and cybersecurity to implant durability, biocompatibility and chemical characterization. We work with a curated network of experienced subject-matter experts and reliable test laboratories, and connect you with the ones that fit your device, budget and timeline.
MEET SOME OF THE EXPERTS
The subject matter experts behind your testing.
Chiara Lorenzetto
Principal Consultant
Chiara Lorenzetto is a Principal Consultant at CardioMed Device Consultants with nearly 20 years of experience in medical device and pharmaceutical product…
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Jasmine D. Patel, PhD
Chief Executive Officer
Dr. Jasmine Patel is the Chief Executive Officer of CardioMed Device Consultants, bringing 20 years of experience in medical device development, regulatory…
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Lynn Bailey
Principal Consultant
Lynn Bailey is a Principal Consultant at CardioMed Device Consultants with more than 35 years of experience in preclinical research, specializing in…
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Meagan Fagan, M.S.
Principal Consultant
Meagan Fagan is a Principal Consultant at CardioMed Device Consultants, bringing more than 19 years of experience in medical device development, regulatory…
Read bio →Ready to advance your device program?
Tell us about your device and timeline.