Biorep Technologies, Inc.
Biorep is ISO 13485 Certified and FDA Registered. As a full-service development firm, Biorep has an exclusive focus on medical products and over 20 years of experience developing medical devices. Biorep enables advancements in medical technologies by offering the single source solution for healthcare professionals and researchers worldwide through a collaborative commitment to the design, development, and manufacturing of innovative biomedical products to improve the quality of life for patients.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
This company also provides solutions for other industrial applications.
Please, visit the following links for more info:
About Us
Biomedical Innovation
- Recognizing the complexity, risk, and rigor associated with developing products for healthcare we focus exclusively on the development of medical devices.
- Developing regulated medical devices is our core competency.
- Our domain knowledge and technical expertise are key differentiators providing significant benefit to our customers. We are proficient in bringing surgical instruments from the first concept to market launch.
Capabilities
Over 25 years delivering innovative solutions
With a sole focus on designing and developing classified medical devices, we have the regulatory registrations and certifications, in-house knowledge, global suppliers and vertically integrated process in place to bring your medical device from concept to launch. As a single source solution for your medical device development we reduce program risk, cut development costs and meet your go-to-market timeline.
Why We Do, What We Do.
At Biorep, we make products that enhance - and save - lives. We manufacture complex medical devices and components for low- and high-volume needs. That's all we do. And we do it with the utmost precision, consistency and rigor, because for you - and your customers - quality is essential. Reliability is a must. And delivering on what's promised is vital.
The Biorep Difference
Biorep delivers value to our customers through decreasing development risk and expediting the time to market. The results speak for themselves.
Biorep Values
Our values define who we are, what we do and how we do it. They influence the way we work with each other –and the way we serve our clients.
Innovation
Biorep Technologies values originality and promotes innovative and strategic thinking to solve current medical challenges. We apply our ingenuity across all aspects of our business and in the products, services, and processes we deliver to our clients.
Integrity
We understand that respect is the fundamental value for successful team work. At Biorep, we believe that honesty and reliability are essential for our progress.
Excellence
We set high standards and we constantly adapt and improve our products based on feedback from the medical community. Biorep prides itself on providing innovative products of the best quality.
Enthusiasm
We are passionate about what we do and are committed to delivering the best solutions to our clients.
Collaboration
We learn from each other and share our skills to enrich the creative process and to provide interdepartmental support. Biorep is committed to collaborating with professionals in the medical field and to delivering excellent service to our clients.
Our History
Thirty seven years ago, Ramon Poo knew almost nothing about diabetes. It didn’t run in his family; it wasn’t on his mind. Then his 4-year-old daughter, Cristina, was diagnosed with juvenile diabetes. That was the original driving force behind Biorep – develop the technology to help researchers find the biological cure for Type I diabetes. “We said this is something we have to do. We all have the dream of finding the cure” – Ramon E. Poo, 2002
Through a close relationship with the Diabetes Research Institute and Dr. Camillo Ricordi, we developed the equipment and method used worldwide for islet isolation research.
Throughout the development of diabetes research equipment, we learned the intricacies of medical device development and ventured into surgical instrument design and manufacturing in collaboration with renowned cardiac surgeon Dr. Joseph Lamelas. Along the way, Biorep became ISO 13485 certified, FDA registered, and built a state-of-the-art class 10,000 cleanroom.
With over ten different FDA compliant medical devices under our belt, we expanded our service offering towards other medical disciplines and are looking to establish ourselves as the leading medical device product development firm in South Florida.
Facility
Miami Lakes facility offers 3D printing, ISO 7 Class 10,000 clean room assembly, kitting ar. packaging, engineering lab, inspection suite, and climate-controlled warehouse. Biorep has over 6.000 square feet of intuitively designed space for optimized process flow and complete traceability to create maximum efficiency
Our Customers
Biorep Technologies has enabled multiple medical device start-ups launch their medical device or lab instrument to market by leveraging our quality system and FDA registration.