Systems Engineering and System Modeling for the Medical Device and Pharmaceutical Industries
SERVICES
SYSTEM MODELING
Predict Real-World Device Performance
Multidomain computational system modeling enables you to predict real-world performance, develop control systems, and test design concepts. Save development time and money by evaluating designs via simulation and reducing the burden of physical testing.
SYSTEMS ENGINEERING
A Systematic Approach to Development
Systems Engineering is a transdisciplinary and integrative approach to enable the successful realization, use, and retirement of engineered systems, using systems principles and concepts, and scientific, technological, and management method.
Requirements Development/Management
Verification Strategy, Planning, and Protocols
Traceability Analysis
System Architecture
Safety Systems
Design Change Management
RISK MANAGEMENT
Reduce Risk to Users and Patients
ISO 14971
System Hazard Analysis
System Risk Assessment (SRA)
Use Error Risk Analysis (UERA)
Failure Modes and Effects Analysis (FMEA)
Fault Tree Analysis (FTA)
MEDICAL DEVICE SOFTWARE
Reliability By Design
Algorithm development and performance metrics
Analytics for End User Device Usage
IEC 62304
COMBINATION PRODUCTS
Drug Delivery Devices
Navigate the intricacies of drug-device combination product development
Ambulatory infusion pumps
On-Body Injectors
Autoinjectors
Pre-filled syringes
DHF REMEDIATION
Ensure Compliance
Stay up-to-date with changing regulations, safety standards, and quality practices. Fix latent documentation issues before they have a chance to be discovered in an audit.
CONTACT
Have a particular challenge you’re trying to deal with? Contact us today and see what we can do for you.
