MedShore Engineering LLC is a technical program management consultancy serving the medical device industry — leading new product development, cross-functional execution, and regulatory-ready product delivery.
MedShore Engineering LLC provides technical program management and engineering leadership to medical device organizations navigating the full arc of new product development — from early concept and design inputs through verification, validation, and commercialization readiness.
We work inside regulated medical device environments: leading cross-functional teams through design controls, risk management, and FDA-facing documentation, while keeping schedule, scope, and stakeholders aligned week to week.
The focus stays narrow and deep — Class I–III medical devices, surgical instrumentation, and capital equipment — so every engagement draws on direct, relevant experience.
Acting as the single point of accountability for a program's schedule, budget, and deliverables — surfacing trade-offs early and keeping technical decisions moving toward launch.
Aligning R&D, quality, manufacturing, and supply chain around a shared timeline, with risks and trade-offs surfaced early.
Running the ceremonies and governance a program calls for — Agile, Waterfall, or Hybrid — across hardware-and-software medtech teams.
Supporting DHF maintenance, risk management, and verification & validation planning within 21 CFR Part 820, ISO 13485:2016, and ISO 14971 frameworks, with FDA readiness in view.
Coordinating supplier qualification and process verification to support a smooth, production-ready transfer.
Translating program status into clear, decision-ready updates for leadership — progress, risk, mitigation, and resourcing.
Reach out about technical program management, engineering leadership, or project-based support for medical device development.
We work with medical device teams wherever they are. Send a note and we'll respond directly.