Medical Device Experience & Industries
Executive Depth: Dual VP Engineering & Director Quality/Regulatory
Springboard Solutions brings medical device executive consulting experience earned at the highest level of technical and regulatory complexity — dual VP Engineering and Director Quality/Regulatory responsibility on one of the most sophisticated Class II devices ever FDA-cleared.
That depth spans every stage of the device lifecycle: FDA 510(k) submission, QMSR (FDA 21 CFR 820) and ISO 13485 QMS implementation, ISO 14971 risk analysis, IEC 60601 and IEC 62304 standards compliance, design control, post-market surveillance, complaint handling, FDA inspection readiness, and 483 remediation — across a 27-person cross-functional organization, three continents, and a $50M+ system with a $200M+ host facility requirement.
Past technical breadth
Past technical breadth supporting this depth includes precision instrumentation for US National Laboratories (DOE/NNSA), OC-3/OC-12/OC-48 SONET telecommunications (Lucent Technologies), industrial process control, and MIL-STD-810G/461 qualified defense-market capital equipment with EAR/ITAR compliance.
Primary markets served
Class I, II, and III medical device manufacturers; life sciences organizations; and companies requiring complex capital equipment expertise. AI-enabled regulatory and QMS services are available through Springboard's strategic partnership with Valere — Top AI Company 2024 (Clutch).
Springboard Solutions Serves the Medical Device & Life Sciences Industries
Primary Markets
Medical Device Manufacturers
• Class I, II, and III devices; capital equipment; combination products; Software as a Medical Device (SaMD)
• Regulatory strategy, FDA 510(k) support, systems integration, and QMS implementation for complex multi-domain devices
• Direct depth: proton radiation therapy — 8-domain Class II, $50M+ system, FDA 510(k) cleared, three-continent installations
Life Sciences Organizations
• Pharmaceutical and biotech companies navigating FDA/ISO alignment, AI regulatory strategy, and QMS implementation
CURRENT ENGINEERING EXPERIENCE (consulting backdrop)
Proton Radiation Therapy
• Class II capital medical device — $50M+ system, $200M+ host facility, 17 US patents, FDA 510(k) cleared, three-continent installations (ProTom International)
X-Ray Security & Threat Detection
• Capital equipment for commercial and defense markets — MIL-STD-810G/461 qualified, EAR/ITAR compliant, $91M+ program (AS&E; / Rapiscan)
AI-Enabled Services — Available across all markets
• Via Springboard's strategic partnership with Valere (Top AI Company 2024, Clutch · 220+ engineers · 5 global offices). Regulatory compliance automation, QMS/QMSR AI integration, and systems intelligence — delivered through a combined People → Process → Tools → Technology framework.
PAST TECHNICAL BREADTH (supporting depth for regulated product environments)
Precision Instrumentation
• Linear & rotary positioning systems for US National Laboratories (DOE / NNSA) and defense prime contractors
Telecommunications
• OC-3/OC-12/OC-48 SONET optical transmission systems — Lucent Technologies
Industrial Automation
• Process control for natural gas production and propane gas peak-shaving facilities
Electronic Manufacturing
• Capital equipment for surface-mount circuit board manufacturing