The Leading Experts in Complex Medical Devices

combo med

EXPERTISE in clinical development and regulatory affairs to execute successful medical device trials across all risk classifications and approval pathways globally.

CAPABILITIES in health economics to develop adjunctive reimbursement and safety surveillance programs and provide ongoing marketing support.

FLEXIBILITY to develop primary devices as well as implantable devices (e.g.,  drug-eluting stents) and device-based drug delivery mechanisms.

Few if any CROs our size have the depth of experience in medical devices that Theorem does — and few qualities are a better indicator of success for your next trial than experience. Over the last two decades, our medical device study team has managed hundreds of complex studies for all classes of medical devices. In fact, Theorem was one of the first CROs managing combination device programs for the development of medical device/drug delivery systems, and the Theorem regulatory team is on the forefront of the development and promulgation of guidelines governing mobile technology. In the course of our extensive work in this field over the past several years, Theorem has developed expertise in several key concepts related to mobile medical technology:

  • General and Regulatory Framework of Mobile Medical Applications and Regulation Standards
  • Software Programing, Off-the-Shelf Software, Cybersecurity, Risk of Mobile Platforms
  • Preclinical and Clinical Operations: Considerations for Mobile Technology Resource Requirements, Usability and Human Factor Requirements
  • Data Integration, Imaging Requirements and Visual Analytics
  • Economic and Reimbursement Considerations for Mobile Technology in a Clinical Trial

Theorem has the development and regulatory expertise to execute successful medical device trials across all risk classifications and approval pathways globally. Furthermore, once a device is cleared for market entry, Theorem’s regulatory and health economics experts develop adjunctive reimbursement and safety surveillance programs and provide ongoing marketing support.

  • Broad Therapeutic Expertise
  • All Risk Classifications and Approval Pathways
  • Specialized Expertise in Drug-Eluting and Drug-Device Delivery Systems
  • Pilot, Pivotal and Post-Surveillance Studies

Services

Medical Device Therapeutic Expertise

Specialty Population

Medical Device Development Services

  • Protocol Development
  • Clinical Studies
    • Pilot
    • Pivotal
    • Registries
  • Regulatory Consulting
  • Adjunctive Reimbursement Programs
  • Safety Surveillance/Observational Programs

All Therapeutic Expertise

  • Cardiovascular
    • Abdominal Aortic Aneurysms
    • Arteriovenous Grafts
    • Atrial Septal Defect
    • Catheterization Puncture Site Closure
    • Coronary Artery Lesions
    • Coronary Disease
    • Peripheral Arterial Disease
    • Restenosis
    • Septal Occluder
    • Stent
    • Thoracic Aortic Aneurysms
  • CNS
    • Alzheimer’s Disease
    • Multiple Sclerosis
    • Pain Management
    • Parkinson’s Disease
    • Stroke
  • Dental Medicine
  • Dermatology
    • Atopic Dermatitis
    • Fillers
    • Psoriasis
    • Sun Damage
    • Urticaria
    • Wound Healing
  • Endocrinology
    • Diabetes
    • Diabetic Foot Ulcers
    • Obesity
  • Gastroenterology
    • Barrett's Esophagus
    • GERD
  • Immunology
    • Hepatitis C
    • Herpes Simplex
    • Immunization
    • Sepsis
    • System Lupus Erythematosus
  • Musculoskeletal
    • Orthopedic
    • Osteoarthritis
    • Spinal Disease
  • Nephrology
    • Chronic Renal Failure
    • Portal Hypertension
  • Oncology
    • Hepatocellular Carcinoma
    • Lung Cancer
    • Metastatic Melanoma
  • Ophthalmology
    • Contact Lubricant
    • Corneal Allograft Rejection
    • Dry Eye
    • LASIK Refractive Surgery
  • Pulmonary
    • Asthma
    • COPD
    • Exposure to Cigarette Smoke
  • Surgery