Every project requires a different blend of creativity, scientific approach, engineering expertise and attention to detail.
Systolic has helped customers with all the challenges listed below (and more).
Project Strategy
Project Management Approach
Development Team Structure
Hardware - Software Trade-Offs
Regulatory & Market Access Strategy
Prototyping Strategy
Manufacturing Strategy
Modularity & Integration
Product Feature Scope
Design for Manufacture
3D CAD & Drawings (SolidWorks)
Computational Analysis / Simulation
Design for Injection Moulding
Design for Machining & Casting
Tolerance Analysis
Unit Cost Reduction
Manufacturing Test Development
Pilot Manufacturing Support
Medical Devices
Design Controls
Design History Files and Technical Files
Medical Device Risk Management (IEC 14971)
Medical Device Quality Management (ISO 13485)
Electronic Medical Device Standards (IEC 60601)
Design Verification & Validation
Project Management
Multi-disciplinary Teams
Project & Resource Planning
Manufacturer Shortlisting & Selection
Product Feature Scope
Remote Collaboration
Robust Change Control
Project Risk Management