Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.

1. CONNECTED INSIGHTS.
EXPERT DELIVERY.
Medical Device and Diagnostic Solutions for every
stage of your product’s development life cycle

2. Getting a medical device to the patient takes more than
good technology in today’s environment. Compelling
evidence and convincing value proposition matter.
Competing priorities and differing stakeholder
definitions of value are driving the need for creative,
connected strategies to get the most from each step
in the development process. And – as evidence is
gathered – it should be used to inform and iterate
regulatory, reimbursement and clinical post-market
strategies.
The device life cycle is interconnected.
Your strategy should be too.
Design & Development
Evidence Development
Funding
Regulatory Submission
Market Development
Obsolescence
Concept & Ideation
Commercialization
ASSESS EXECUTESTRATEGIZE
Define product and its
differentiators and
set business goals
Determine plan and
timeline for reaching
those goals
Run your studies
and trials, evaluate
evidence
COMMERCIALIZE
Access market,
satisfy stakeholders,
post-market vigilance
Ask the RIGHT questions.
Set your strategic plan up for success
by aligning your evidence development
plan with your product goals and
stakeholder values.
Non-clinical First-in-Human Feasibility Pivotal Submission
& Post-Market
Regulatory
Affairs
Quality
Systems
Health Economics
& Reimbursement
Clinical Sciences &
Device Consulting
Connected Insights
Expert Delivery
Enterprise-wide Device Portfolio
at Every Stage of the Product Life Cycle

3. Connected Insights. Expert Delivery.
Collaborate with specialists who are among the most experienced
in the industry.
With advisors who are specialized in medical device and diagnostic development, in a variety of disciplines, we help
you achieve your product goals by designing and executing integrated strategies for robust evidence generation to meet
stakeholder demands for successful commercialization.
Regulatory
Affairs
Regulatory Compliance Consulting • Regulatory Strategy • Project Management
Device Claims Development • Labeling • Design Control Support
Regulatory Submissions • Audit Preparation & Support • Regulatory Interface Support
Registration & Licensing Support • Clinical Evaluation Reports (CERs)
Quality
Systems
Quality Systems Strategy • Quality Compliance Support • SOP Drafting & Review
Document Control System Implementation • Remediation Programs
Quality System Audits • Risk Management Support
Health
Economics &
Reimbursement
Strategic Reimbursement Assessments • Strategic Planning • Payer Initiatives
Health Economics Strategy • Heath Economic Assessments
Health Economics Tool Development • Study Budgets
Reimbursement for Medical Devices • Medical Coding
Payer Insights & Payer Mix Analysis • Pricing Strategies
Clinical
Sciences
Clinical Strategy • Clinical Study Design • Clinical Study Operations • Site Management
Site Monitoring Services • Database Development & Management
Data Management • Biostatistics Consulting • Medical Writing
Data Monitoring Committee (DMC) Management
Data Safety Monitoring Board (DSMB) Management
Clinical Events Committee (CEC) Management • Clinical Compliance/Auditing
Device
Consulting
Evidence Development Plans • Medical Device Strategy
Risk Assessment & Management • Acquisition Due Diligence
Integration Planning & Management
Merger & Acquisition Support
A program that’s strategically integrated and passionately executed.
A strategy is only as good as its execution. Put your strategy into motion, leveraging our scientific team, insightful data and
global laboratories. An integrated approach ensures you execute the right studies and trials at any stage of your product’s
life cycle – nonclinical, clinical and post-market. Collaborate with a dedicated team who is as passionate about your product
development success as you are.

4. Learn more about our device development solutions at www.covance.com/device-cro
Covance is a business segment of LabCorp, a leading global life sciences company, which
provides contract research services to the drug, medical device and diagnostic, crop
protection and chemical industries. COVANCE is a registered trademark and the marketing
name for Covance Inc. and its subsidiaries around the world.
www.covance.com
© Copyright 2020 Covance Inc. BRODEV002-0220
Expert. Exact. Effective.
Technology & Product Experience
▶ ablation products
▶ bioelectric devices
▶ biologic devices
▶ combination products
▶ critical care
▶ device delivery systems
▶ dental implants
▶ dermal fillers
▶ imaging technologies
▶ implantable devices
▶ in vitro diagnostics (IVD)
▶ in vitro fertilization (IVF)
▶ wound healing: meshes/fabrics
▶ neurostimulators
▶ neurovascular devices
▶ orthopedic/spine implants
▶ pacing leads
▶ peripheral vascular devices
▶ pulmonary products
▶ stents
▶ surgical instruments
▶ surgical technologies
▶ tissue adhesives sealants
▶ urinary incontinence bulking agents
Therapeutic Area Experience
▶ cardiology/cardiovascular disease
▶ chronic disease
▶ central and peripheral nervous system
▶ dental/oral health
▶ dermatology
▶ diabetes
▶ ear, nose, throat (ENT)
▶ genetic disease
▶ gastroenterology
▶ hematology
▶ nephrology
▶ neurology
▶ nutrition and weight loss
▶ obstetrics/gynecology
▶ oncology
▶ ophthalmology
▶ orthopedics
▶ pain management
▶ pulmonology/respiration
▶ urology
▶ trauma
▶ wound healing