Cosm — Product development, quality, and regulatory consulting.

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 some quick questions before getting into all the details?Send us a quick email.

send us an email

‍

what we do

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-orientated 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.

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.

our team

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!