How we work
Every engagement starts with your device and your next milestone. We scope the work in writing, do it hands-on with your team, and leave you with documents you own.
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.
What to expect
- You own and approve every document we produce.
- Work beyond the agreed hours is billed at the hourly rate.
- We provide engineering and quality support, not regulatory submission authorship.
The experience behind Valivera
Our founder
Lara de Vries
Founder and Medical Device Design & Quality Engineer
MS, Systems Engineering
University of Central Florida
BS, Biomedical Engineering
University of South Florida
- 6+ years as an engineer in the medical device industry, across Class II and III devices and biologics
- Supported 510(k) and PMA submissions, plus multiple Pre-Submissions and Q-Submissions
- Six Sigma Yellow Belt and formal root cause analysis training
- Member of ASQ
Every device I work on is ultimately for two people: the patient who depends on it and the physician who uses it. That principle guides my career in medical devices.
I chose this industry because one well-designed device can improve care for thousands of patients, and I have stayed close to the clinical side of the work: supporting surgical cases, leading compassionate use and PS-IDE programs, and co-presenting with a physician at Stent Summit on reducing secondary interventions after physician-modified endografts.
My foundation is in R&D and sustaining engineering, where I work through design controls (from user needs to design transfer). In my current role, I pair that hands-on product experience with compliance and risk management. I understand both how a device is built and what it takes to prove it is safe and effective.
As the founder of Valivera, I help small medical device companies and pre-510(k) startups build design controls, risk management files, and audit-ready design history files. If you are developing a device and want a partner from concept through release, book a call or send us a message below.
6+ yrs
In the medical device industry as an engineer
Class II · III
Devices, plus biologics
510(k) · PMA
Submissions supported, plus Pre-Subs and Q-Subs
EN · ES
Fluent in English and Spanish
Path
R&D and sustaining engineering
Design controls from user needs to design transfer, across Class II and III devices and biologics.
Compliance and risk management
CAPA ownership, risk files, and 510(k), PMA and Pre-Sub support.
Founded Valivera
Design controls, risk management and audit-ready DHFs for medtech startups.
Core expertise
- Design controls and design history files (ISO 13485, FDA QMSR)
- Risk management (ISO 14971, hazard analysis, design FMEA)
- Verification and validation planning and execution
- CAPA ownership, from root cause investigation through verified effectiveness
- Compassionate use, PS-IDE, and FDA Pre-Sub and IDE readiness
- Fluent in English and Spanish
Standards we work to
- ISO 13485:2016, clause 7.3
- ISO 14971:2019
- FDA QMSR (21 CFR 820)
- ISO 11607
- ISO 10555
- ISO 9001
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