Concept to production engineering solutions
for your product design project.
Requirements Management/Architecture
Experience in the art of writing requirements that are technically feasible, unambiguous and testable
Many years of experience in architecture development, in SysML, for complex hardware and software systems
Proof of Concept Development & Prototype Design
Technical feasibility for many different proof of concepts in medical and commercial industry
Early risk identification and reduction
Design for Safety, EMC & Regulatory Compliance
Multiple product certification cycles for class I and class II devices
Risk management (per ISO 14971) for PHA, DFMEA and UFMEA plus Hazard and Harm lists
Verification / Validation Test Development and Execution
Expertise in mechanical, electrical and reliability verification techniques
Work with vendors on biocompatibility and sterilization verifications
Usability Engineering
Expertise in IEC 60601-1-6 and IEC 62366
Usability Engineering File, Usability FMEA, Validation test protocol development, clinical surveys and Validation reports
Design History File Remediation
Scope
Review customer DHF files for compliance with EU/MDR requirements for 200+ part numbers
Schedule
1yr
Results
Completely rebuild DHF with new requirements documentation, support for verification and validation testing
Industrial Power System Documentation
Scope
Support development of CDRL and SDRL documents for Department of Defense contract
Schedule
5 mos.
Results
Developed and submitted 30+ documents to Tier 1 Prime Contractor review and approval
Development of Novel Orthopedic Device
Scope
Assist startup with requirements and architecture for a new orthopedic device
Schedule
6 mos.
Results
Developed architecture, requirements and FMEA / risk analysis for Hazards, cybersecurity and usability to inform requirements
Certification Support – Medical Imaging Device
Scope
Lead certification effort for IEC 60601-1 and IEC 60601-2 plus EU/MDR EMC requirements
Schedule
3 mos.
Results
Provided onsite support for passing EMC testing and IEC 60601 compliance, plus lead effort on another product that was in design