Engineering and Scientific Consulting

Medical Device Product Development

Design
Review

Design
Review

Validate
& Design
Transfer

Design
& Verify

Feasibility

QMS

gap analysis
and
preclinical evaluation
strategy
Technology
assessment
Competitive
intelligence
Intellectual property
analysis
Medical and
economic assessment
of medical devices
M&A due diligence
Identification of
critical to customer
requirements
Product
specifications and
development plan
Regulatory

Test method
development
Electromechanical,
thermal finite
element modeling
and testing
Implement design
controls
Hazard analysis/
FMEA
MRI compatibility
testing
Biomaterials
selection
Preclinical testing
strategy
Cost effectivenes
Biocompatibility and
thromboresistance

Supplier
qualification/
selection
Reliability
engineering
Human factors in
product design and
Function
Use comparison with
competitive products
Risk management
report clinical study
design
Device labeling
support
Regulatory
compliance

Design
Review

Design
Review
Manufacture
& Launch
Manufacturing
process
troubleshooting
Process control/
quality assurance
Process validation,
and statistical data
analysis
Contamination
control in
manufacturing
operations
Product
differentiation
510(k)/PMA
regulatory filings
Packaging/labeling
requirements
Healthcare utilization

Post Market
Surveillance
Safety and
performance
assessments
Device retrieval
analysis and product
recalls
Medical device
reporting (MDR)
Corrective and
preventive actions
(CAPAs)
Post marketing
surveillance
Registry design
Health economics
and outcomes
research
IP support

Risk Management Data Analysis Technical File/Design Dossier CER PMA-IDE/510(k)

Combination Devices Toxicology Epidemiology Safety Surveillance Regulatory Health Outcomes
w w w. e x p o n e n t . c o m

888.656.3976

info@exponent.com