Where we started
RAC Medical started in 2012 after spending years leading development for many medical products across big and small companies - some successful and some not. RAC Medical sprung out of a passion to teach and navigate others through the complex medical device process of achieving regulatory clearance and commercializing a product that users actually want and can use.
Our passion is driven by seeing many projects fail, or miss the mark, for a number of reasons with the biggest reason being that teams just didn’t have the whole picture or story. Without having all of the information, innovators aren’t able make decisions and build products that are successful. Even more importantly, it’s knowing how to narrate and craft a story that enables someone to understand how to interpret the picture accurately. Using the Feyman technique, we simplify the process and craft a story that helps innovators understand what’s needed to get their product to market.
Here we are in 2020, continuously crafting our own story in an ever growing and every evolving industry. We’ve helped many companies - big and small - successfully get their products to market. We quickly became the go-to partner for SaMD products and technologies using AI/ML and Deep Learning. We thrive in working in the unknown and pushing the boundaries. We love challenges and being challenged. Now we have a brand that better aligns with who we are.
Finding the new us
To create our new brand, we started with a long and hard look in the mirror. We really wanted to hone in on a central vision that was more specific, a clear message that captures our personality, approach, and how we solve challenges as a team. We wanted to create true alignment for our team and clients. A lot of revealing, split-a-bottle-of wine worthy questions followed.
We knew that we always wanted to be co-creating transformative products with ambitious thinkers and doers. And that will never change.
But, we wanted to emphasize that we are your partners - providing education, key guidance, and comprehensive services that allow you to be more successful and get your products in the hands of the users that need them, frictionlessly.
Welcome to Cosm.
Cosm is a boutique agency providing end-to-end regulatory, quality, product development, usability, and marketing services. We help navigate the nuances of each possible decision so you can clearly weigh options and keep things moving forward. We’re fully committed to helping you see the whole picture in order to build product experiences that last, while challenging your ways of thinking to ensure you have considered everything in the process. Not only do we want to make you become more successful as a company, we want to collectively change the lives of users while empowering them to take control of their own lives with your products.
Building innovative and powerful products excites us and we did not want our efforts to end at clearance or approval. We intertwine marketing efforts from the start when we navigated the nuances of how to bring your product to life and for whom your product is for. So, we expanded our services to help give your product a voice and reach your users. We want to follow through on the success and celebrate the milestones alongside you.
We actively guide and educate you through the Regulatory process while delivering your strategy and implementation. Our goal is to create the most considered path that enables you to commercialize faster and cheaper.
We have deep experience with electro-mechanical design, architecture design, design for compliance to standards, and software development.
Quality Management System
Your QMS should evolve as your product life cycle evolves. Whether you have a traditional device or software-only product, we have you covered from FDA QSR to ISO 13485.
Reach users with messaging that’s both effective and within regulations. Whether it's preparing for GTM, telling your story, or optimizing user acquisition, we have you covered.
Our Core Values
Everything we do is to help your team launch products, so things have to keep moving forward in both small and big ways.
We keep it real. You don’t have time or resources to waste and we respect that. Our instincts are to be clear-eyed, plain-spoken, and candid knowing that stakes are high.
It’s absolutely key to overcome blindspots and see the whole picture when building products that last. We thrive on details – both for context and color.
Where we will go, together
Our vision is to create a thriving community & resource hub educating a growing population of entrepreneurs bringing regulated devices to market. In order to do this successfully, we always need to be learning and growing ourselves.
We strongly value your opinion and want to ensure that our brand refresh resonates with you. Don't hesitate to let us know what you think.