product development
Feasibility Studies Support
- QMS gap analysis
- Regulatory 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
Design & Verify
- 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 effectiveness
- Biocompatibility and thromboresistance
Validate & Design Transfer
- Supplier qualification/ selection
- Reliability engineering
- Human factors in product design and Function
- Product use comparison with competitive products on market
- Risk management report clinical study design
- Device labeling support
- Regulatory compliance
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