Engineering and quality support, built around your device
Fixed-scope packages for medical device teams, from first design inputs to on-market sustaining. Every engagement keeps the patient and the physician at the center of the work.
Book a consultDesign Controls Foundation
$2,700
fixed
Who it's for: Startups turning a prototype into a traceable, reviewable design.
- User needs translated into testable design inputs
- Design and development plan built for your stage
- Traceability matrix from user needs to V&V
- Gap check of existing design files, with a prioritized fix list
About 24 hours over 4 weeks
Risk and Verification Readiness
$3,200
fixed
Who it's for: Teams heading into design verification or a 510(k).
- Design FMEA and ISO 14971 hazard analysis, built or reviewed with your team
- Risk controls traced to requirements and test evidence
- Test method and TMV plan
- Verification plan with sample sizes justified by risk
About 28 hours over 5 weeks
Sustaining and CAPA Partner
$1,800
a month, 3-month minimum
Who it's for: Companies with devices on the market or close to launch.
- CAPA investigations, root cause, and effectiveness checks
- Design change impact assessments
- FMEA, risk file, and TMV updates as your design changes
- Design reviews, with questions answered within 2 business days
Up to 16 hours a month
Need something more focused? Hourly support is available at $115 an hour. Get in touch.
$115 an hour, flat
For a single design review, a protocol read-through or a question before an audit, billed for the time the work takes.
Book hourly time$1,380
12 × $115 an hour
Paying by the hour fits work like this. If you need support every month, the Sustaining and CAPA Partner reserves up to 16 hours for $1,800 a month, with questions answered within 2 business days.
Let's talk about your device
Tell us where your design stands and what milestone is next. Book a 30-minute intro call, or send a message and we'll reply by email.
Book a 30-minute intro call