“Your involvement was extremely valuable to the project. I very much appreciate the expertise and support you provided throughout the entire process.”

—President and CEO, Startup Medical Device Company

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Unsurpassed Depth and Breadth

LyChron's team offers years of experience in developing and overseeing scientific research for medical devices and therapies in healthy and disease models. Our case experience spans everything from non-invasive and minimally invasive interventional procedures to open-chest, on-pump surgical procedures.

Disciplines

Cardiac
Dental
Dermatological
Gene and Cell Therapies
Gastrointestinal
Neurological
Ophthalmic

Orthopedic
Pulmonary
Reproductive
Urogenital
Vascular
And more

Medical Devices

Stents (drug eluting, bifurcation, coronary, neurological, endovascular, peripheral)
Aneurysm Grafts
Vascular Closures
Gastric Implants
Orthopedic Implants
Imaging Systems
Sleep Apnea Devices
Combination Drug/Device,
Cell/Device Products
Lasers
Pacemakers
Electrophysiology Telemetry Monitors
Electrophysiology Mapping Systems

Patent Foramen Ovale Closure Systems
Neurostimulators
Embolic Protection Devices
Heart Valves
Venous Reflux Devices
Wound Closures
Coagulation Devices
Reproductive Sterilization Devices
Radiofrequency and Cryoablation Systems
Bone Marrow Extraction Devices
Tendon Repair Devices
Spinal Fusion Devices
Incontinence Treatment Devices
And more

Therapies

Regenerative Applications
Pharmacokinetic Evaluations of Pharmacological Agents or Combination Products

Study Design Assistance and Model Selection
LyChron frequently works with clients to select and refine testing models for in vitro, human anatomical specimens and non-primate in vivo research. Our technical, veterinary, and management teams have years of experience optimizing the design of feasibility, proof-of-concept, and product development studies. We can help you finalize your study design by selecting the best species, specific anatomy, and other key parameters for completing a successful experiment the first time. To contact a LyChron veterinarian or technical specialist, please write

Good Laboratory Practice (GLP) Studies
Expertise The U.S. Food and Drug Administration (FDA), under provisions of the Federal Food, Drug, and Cosmetic Act, mandates and enforces GLP safety regulations outlined in the Title 21 Code of Federal Regulations (CFR) Part 58. Completing GLP-compliant studies in a timely manner with accurate, substantiated data is essential for successfully launching new healthcare products.

With hundreds of GLP-compliant studies completed for medical devices and therapies since 2001, LyChron has earned an international reputation as a pre-clinical laboratory you can trust. Our GLP quality system addresses 21 CFR Part 58 and 21 CFR Part 11 requirements and provides experienced study directors and quality assurance specialists to assist with individual study needs. We have successfully completed two FDA inspections with no 483 observations.

To stay abreast of current FDA positions and policies, our regulatory, quality assurance, and technical teams are involved in professional forums such as the Medical Device Specialty Section of the Society of Quality Assurance, regulatory conferences, and industry focus groups, including the discussion panel sponsored by the Advanced Medical Technology Association (AdvaMed) for the FDA’s Drug Eluting Stent Guidance Document.

LyChron's People >

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