Move fast. Stay compliant. innovate confidently.
Many medtech startups run into costly mistakes and delays because moving from prototype to a clinically ready, regulatory-compliant product can be complicated, and confusing.
We help medtech startups navigate this transition by providing expert guidance along with structure and tools — clear roadmaps, practical templates — allowing teams to move forward efficiently and with confidence.
Comprehensive Solutions for Medtech Startups
As a small, focused consultancy, we work closely with a limited number of medtech startups to provide complete quality and operational support. Get fractional expertise with everything included – no need to manage multiple consultants or piece together your infrastructure.
Fractional Quality & Operational Services
Expert oversight and strategic guidance throughout your product development lifecycle. Choose your commitment level and we prioritize the highest-impact work.
✓ Quality oversight & accountability
✓ Design conrol and risk management facilitation
✓ Strategies for complex challenges
✓ Supplier evaluations and oversight
✓ Regulatory submission support
✓ Access to vetted partners (biocompatibility, sourcing, etc.)
Flexible Monthly Committment
Start-up level pricing. Scale hours up or down as your roadmap evolves.
Complete QMS Implementation
Start developing under an audit-ready Quality Management System immediately. Fully configured to your team with SOPs, templates, and documentation ready to use.
Included with Fractional Services
No additional setup fees.
ISO 13485-Compliant Document Control
Enterprise-grade document management without the enterprise cost. 21 CFR Part 11-compliant approvals, unlimited storage, and full traceability from day one.
Included with Fractional Services
No separate $$$ eQMS contracts.
On-Demand Options
Choose these on-demand options any time. No fractional agreement required.
Quick Start QMS Packages
- Startup QMS
- Growth to Clinical
- Market Approval Ready
Audits
- Spot Check
- Standard Audit + Detailed Report
- Interactive Audit (add Live-Feedback & Training)
Supplier Evaluations
- Supplier Spot Check
- Supplier Evaluation & ASL Plan
- Evaluation + On-site Audit
Gap Assessments
Detailed review of your company’s processes against applicable standards.
The All-In-One Difference: Traditional consulting requires you to coordinate multiple contractors and full-time hires, purchase separate document control software, and design your own QMS. Our fractional model includes everything you need in one package, saving you time, money, and the headache of managing multiple relationships.
Why Choose Crane Medtech Partners
Personalized Partnership
Small team, deep engagement. No layers of junior staff.
Built for Startups
Built specifically for venture-backed and early stage teams
Deep Technical Knowledge
Deep experience in Class III neurotech and across medtech
Right-Sized Systems
Lean, phase-appropriate systems (not overbuilt)
Hands-on Execution
Execution, focused support, not theoretical consulting
Don’t just take our word for it…
“If you’re trying to get from concept to clinical reality without derailing on compliance or execution, she’s exactly who you want involved.”
– Michel Maharbiz, CEO of iota Bisociences
“Rebecca brings speed, agility, and regulatory rigor to complex, high-stakes projects, earning trust quickly and delivering clear results.”
– Strategic Advisor at Leading US Medical Device Company, Southern California
“An absolute force for good in our organization. She bridges quality and engineering so teams can move fast.”
– Technical Program Manager, Neuro Startup, Bay Area
“She brings clarity and perseverance to even the toughest challenges, delivering practical, high-impact solutions with a calm, thoughtful approach that earns trust and gets outcomes.”
– Design Quality Leader, Surgical Navigation Startup, Minneapolis area
Learn more about us
We don’t just advise, we dig in.
We team up with medtech innovators to move fast, stay compliant, and tackle the tough stuff that slows others down.
Crane Medtech Partners 