Know
your way
forward.
Breakthrough regulatory strategy with built-in product development for health technology companies.
get startedOur Services
Regulatory • Product Development
Quality • Clinical • Usability • Marketing
You must be wondering
You must be wondering
what your regulatory pathway looks like.
You must be wondering
what data is needed for FDA clearance or approval.
You must be wondering
how the FDA deals with AI/ML products.
You must be wondering
if your device is regulated.
Have questions before getting into all the details?
Send us an email.
Basically, it works like this
We’ll be your go-to guide through the nuances of each possible decision so you can clearly weigh options and take the best pathway forward.
We believe it’s a delicate balancing act between being action-oriented and making sure we’re un-siloed in our problem solving.
Regulatory
Breakthrough regulatory guidance
We actively guide and educate you through the FDA and regulatory process to create the most considered path for your product.
Understand specific product requirements, define your regulatory strategy and gain implementation support to get you to market faster and cheaper.
product development
Build in unison
Our comprehensive regulatory approach
tightly integrates your product roadmap at every step: usability testing, safety & compliance, and developing key features.
Avoid surprises, build the best possible product, and get to market faster.
Quality management system
Tailor-made to scale
We make it a rule that your QMS evolves as your product life cycle evolves. Whether you have a traditional device or software-only product, we have you covered from the FDA QSR to ISO 13485.
clinical studies
Proving how our
process works
Choosing the right clinical study plan,
design, and execution can be overwhelming. We unpack this from the start, so your product development and regulatory decisions are made together.
We help both in the U.S. and internationally.
Marketing
Stand out with the
right voice
Reach users with powerful messaging that’s both consistent, effective, and within regulations.
Whether it’s building a GTM strategy from scratch, telling your story, or optimizing user acquisition, we have you covered.
Build in unison
Our comprehensive regulatory approach tightly integrates your product roadmap at every step: usability testing, safety & compliance, and developing key features.
Avoid surprises, build the best possible product, and get to market faster.
Tailor-made to scale
We make it a rule that your QMS evolves as your product life cycle evolves.
Whether you have a traditional device or software-only product, we have you covered from the FDA QSR to ISO 13485.
Proving how our process works
Choosing the right clinical study plan, design, and execution can be overwhelming. We unpack this from the start, so your product development and regulatory decisions are made together.
We help both in the U.S. and internationally.
Stand out with the right voice.
Reach users with powerful messaging that’s both consistent, effective, and within regulations.
Whether it’s building a GTM strategy from scratch, telling your story, or optimizing user acquisition, we have you covered.
We are equal parts educators and doers.
Our goal is simple: make things far less complicated so you can keep moving forward with confidence. After all, the world needs your product.
We also understand that the stakes can be high and speed is key. Whether you’re building from scratch or need help on the last mile, let us help.
Rory A. Carrillo
Product, Regulatory & Quality
Your passionate, boundary-pushing guru helping create life changing products. When he is not simplifying nuanced concepts, you can find him traveling the globe experiencing new cultures, food and live music.
Kateryna Borysova
UI/UX Designer
Your creative and devoted to work UI/UX designer. When she is not working on modern and user-friendly solutions for new projects, you can find her traveling, learning languages or seeking for inspiration in painting
Claudia Murillo
Regulatory & Quality
Your ambitious, user-focused, and highly organized quality distiller. When she is not helping you improve lives, you can find her practicing yoga and sourcing food from her local farmers market to nurture her own!
Tanya Schikorr
Principal Consultant
Engineering, Marketing, Health Economics & Reimbursement.
Bryan Comstock
Advisor
Academic and Entrepreneurial Biostatistician.
Antonius Wiehler
Biostatistician
Academic and Entrepreneurial Biostatistician.
What our clients are saying
Shall we start?
Solving incredibly challenging and nuanced problems is our thing. Tell us about your project – it can make all the difference.
Get startedWhat our clients are saying
Shall we start?
Solving incredibly challenging and nuanced problems is our thing. Tell us about your project – it can make all the difference.
Get started