Know
your way
forward.

Breakthrough regulatory strategy with built-in product development for health technology companies.

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Our Services

Regulatory Product Development
Quality Clinical Usability Marketing

You must be wondering

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.

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-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.

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!

Tanya Schikorr

Principal Consultant

Engineering, Marketing, Health Economics & Reimbursement.

Bryan Comstock

Advisor

Academic and Entrepreneurial Biostatistician.

Antonius Wiehler

Biostatistician

Academic and Entrepreneurial Biostatistician.

testimonials

What our clients are saying

Rory helped us create a sustainable QMS and supported us in receiving 510(k) clearance on several of our products. His deep understanding of SaMD, clinical and machine learning principles were critical in leading us to success, as the more 510(k)’s we receive, the more sustainable we become as a business.

We were able to get a much clearer answer on how we would be regulated, and which claims we could and could not make. Rory also helped us reduce ambiguity and troubleshoot changes needed to get much closer to a final product design for our users. He’s able to interpret complex and intersecting regulatory concepts and distill them into action items we needed.

Before Cosm, we were unclear of our regulatory pathway for our product and how we were going to launch. Working with Rory was critical to our success thus far, as he helped us navigate through some transitions between a general wellness device and medical device and reimbursement processes. His transparency was valued, along with his warm, personal service.

Working with Cosm helped us prepare for the level of detail and documentation required in the medical field to show our product can be safe and effective. They’re very knowledgeable and ready to start from day one, bringing us a complete outline of reference materials we needed. I felt assured that Cosm has done this before and will provide a level of expertise needed to give us the best chance at FDA approval.

Rory was critical in shepherding us through our regulatory strategy and ultimately to our FDA clearance on a medical device. Getting our FDA clearance was a big win, obviously, but the longer term win was the hard work Rory did to set up our quality system in a logical, scalable way to grow with our team and business needs.

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
testimonials

What our clients are saying

Rory helped us create a sustainable QMS and supported us in receiving 510(k) clearance on several of our products. His deep understanding of SaMD, clinical and machine learning principles were critical in leading us to success, as the more 510(k)’s we receive, the more sustainable we become as a business.
We were able to get a much clearer answer on how we would be regulated, and which claims we could and could not make. Rory also helped us reduce ambiguity and troubleshoot changes needed to get much closer to a final product design for our users. He’s able to interpret complex and intersecting regulatory concepts and distill them into action items we needed.
Before Cosm, we were unclear of our regulatory pathway for our product and how we were going to launch. Working with Rory was critical to our success thus far, as he helped us navigate through some transitions between a general wellness device and medical device and reimbursement processes. His transparency was valued, along with his warm, personal service.

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