Your Quality Management System, Built Right

Prime Path handles QMS development, ISO 13485 consulting, and audit preparation so your device team can focus on the product, not the paperwork.
Let's Build Your Quality Foundation
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Know exactly what your company needs

These three tiers give you a starting scope — every engagement is refined once we understand your device and timeline.
Tier 1
Audit Ready
Starting at (price)
✓
Gap Assessment against ISO 13485
✓
Core SOP & document templates
✓
Document control setup
tier 2 • Most common
Certification Support
Starting at (price)
✓
Full QMS build-out
✓
Mock audit & corrective actions
✓
Direct support through certification
Tier 3
Full QMS Partner
Starting at (price)
✓
Ongoing QMS management
✓
Staff training & internal audits
✓
Quarterly management review support

Why Prime Path?

Prime Path was founded to be the partner we wish we’d had – an integrated team that could handle regulatory, quality, and clinical work with the speed and flexibility lean MedTech teams actually need.

Our team is engineer-led, so we understand your device from the inside out, not just the paperwork around it. We support companies across the full product lifecycle, from early strategy through post-market, so you’re not juggling separate vendors as your needs evolve. And because we work on a fractional basis, you get expertise exactly when you need it, without the cost or commitment of a full-time hire.

Experience Across Disease States

Prime Path has worked with medical device teams acorss 20+ disease states:

Orthodontic Malocclusion
Dental Implants / Oral Surgery
Hematology
Orthopedic
Physical Therapy
Urogynecology
General Dentistry
Oncology / Histology
Urology / Incontinence
Sleep Apnea
Oncology / Radiation
Infertility / OB
Bruxism
Oncology / Biopsy
Gastroenterology
Cardiovascular
Neurosurgery
Wound Care
Vascular
General Surgery
Drug Delivery Systems