Design controls and DHF
User needs, design inputs, development plans and traceability, built into an audit-ready design history file.
Product development and Design quality for medtech startups
Product development support from design inputs through V&V, CAPAs closed from root cause to effectiveness check, and risk management gap analysis (ISO 14971) carried through to a complete file.
6+ yrs
Medical device engineering experience
Class II · III
Devices, plus biologics
510(k) · PMA
Submissions supported
From idea to market
We support every stage of your device's life
User needs
Clinical and user needs turned into testable design inputs.
Design controls
A development plan and traceability from user needs to V&V.
Risk management
Hazard analysis and design FMEA under ISO 14971.
Verification & validation
Test methods, TMV and risk-based sample sizes.
Launch readiness
An audit-ready DHF, with support for Pre-Subs and 510(k) preparation.
Sustain
CAPA, design changes and risk file upkeep on the market.
About Valivera
Quality built into every device, from the first input
Valivera helps turn promising medical device ideas into safe, market-ready products, building the design controls, risk management, and evidence needed, right the first time.
Our vision: A future where every medical device reaches patients and physicians designed right, built right, and worthy of their trust.
- Patient safety first
- Results you can measure
- Evidence over assumption
- Built in, not bolted on
What we do
Engineering and quality services across the device lifecycle
Focused support for medical device teams, from first design inputs to on-market sustaining.
Risk management
ISO 14971 risk management plans, hazard analysis and design FMEA, with risk controls traced to requirements.
Verification and validation
Verification plans with sample sizes justified by risk, test methods and test method validation.
CAPA and root cause
CAPA investigations carried from root cause to a verified effectiveness check.
Design change and sustaining
Design change impact assessments, with FMEA, risk file and TMV updates as the design evolves.
Regulatory readiness
Engineering and quality support for Pre-Subs, IDE and PS-IDE programs, compassionate use and 510(k) preparation.
What guides us
Our values
Patient safety first
Every decision traces back to the patient who depends on the device and the physician who uses it.
Results you can measure
Clear deliverables, closed actions and effectiveness checks you can show an auditor.
Evidence over assumption
Requirements, risks and tests linked, so every claim has proof behind it.
Built in, not bolted on
Quality designed into the product from the first input, not added the week before an audit.
Packages and fees
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. Or by the hour at $115. See how the rate works
Design Controls Foundation
$2,700
fixed
Who it's for: Startups turning a prototype into a traceable, reviewable design.
Risk and Verification Readiness
$3,200
fixed
Who it's for: Teams heading into design verification or a 510(k).
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.
Have a device to discuss?
Book a 30-minute callHow we work
A clear path from first call to finished file
Intro call
A 30-minute call to understand your device, its class and your next milestone.
Scope and proposal
A written scope with the package or hours, timeline and deliverables.
Engineering and quality work
Hands-on work with your team. You own and approve every document.
Hand-off and support
Documents ready for review, with ongoing support available hourly or monthly.
Tools and resources
Practical tools and references for medical device teams, from shelf-life calculations to the standards and FDA documents we work with every day.
Resources include:
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