About your company
Tell us who we’d be working with.
Company Name
*
Website
Your Name
*
Title
Email
*
example@example.com
Phone
Please enter a valid phone number.
Format: (000) 000-0000.
Company Size
1–10 employees
11–50
51–200
201–500
500+
Company Stage
Pre-seed
Seed
Series A
Series B+
Established
Enterprise
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Your device
Tell us about the product you’re developing.
Device Name
Brief Device Description
Anticipated Device Class
Class I (Low risk, general controls)
Class II (Moderate risk, 510(k) typically)
Class III (High risk, PMA required)
Not sure yet
Device Type
Hardware device
Software (SaMD)
Combination product
IVD / Diagnostic
Wearable
Implantable
Other
Target Markets
United States (FDA)
European Union (MDR)
United Kingdom (MHRA)
Canada (Health Canada)
Australia (TGA)
Japan (PMDA)
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Regulatory & quality posture
Where are you today, and where do you need to be?
Anticipated Regulatory Pathway
510(k)
De Novo
PMA
CE Mark (MDR)
Exempt
Not sure yet
Current QMS Status
*
No QMS in place — Starting from scratch
In development — Partial procedures drafted
ISO 13485 certified — Certificate in hand
21 CFR 820 compliant — FDA establishment registered
ISO 13485 + 21 CFR 820
Needs audit / remediation
Services Needed
QMS implementation
Regulatory submission
Design controls / DHF
Risk management (ISO 14971)
Internal audit / mock FDA
CAPA program
Supplier qualification
Post-market surveillance
Clinical evaluation
Team training
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Project scope
Last few details so we can route you to the right senior consultant.
Desired Timeline
*
Immediate (Starting within 2 weeks)
1–3 months
3–6 months
6–12 months
Exploratory (Gathering information)
Budget Range
Under $25K
$25K – $75K
$75K – $150K
$150K+
Not sure yet
Tell us about your project
How did you hear about us?
Referral
Search engine
LinkedIn
Conference
Publication
Other
Other
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