Bridging Technical and Strategic Gaps in MedTech with Fractional Expertise
MIS Fractional connects MedTech OEMs and CDMOs with fractional experts through short-
term, virtual consulting. Our team of seasoned professionals, each with over 20 years of
MedTech experience, offers specialized expertise in:
- Regulatory compliance (FDA QSR, EU MDR/IVDR, ISO 13485, ISO 14971, PMA/510(k)).
- Polymer processing and extrusion (micro-bore, multi-lumen, tight-tolerance tubing).
- Complex catheters, balloon technologies & delivery systems.
- Systems engineering & product. development for complex instrumentation
- Automation, machine design & controls integration.
- Strategic planning, leadership development & profitable growth.
We support clients across the full product lifecycle—from ideation through design, validation,
manufacturing, market entry and commercial growth—while empowering our experts to work
flexibly on their terms, fostering collaboration and measurable success.
Whether you’re a startup needing FDA compliance guidance, a CMO optimizing extrusion
processes, or a company seeking profitable growth through innovation and scale-up, MIS
Fractional delivers targeted technical and strategic consulting services to accelerate
development, ensure compliance, and drive results.