MedTech product development company with focus on people, technology and innovation
Since 2011, we have helped MedTech customers with everything from business development to finalizing products for the market. Our customers are helped by our innovative product and system solutions, and of course, we are responsive to the customer’s needs so we can work both at the customer’s premises or in our premises in Malmö (Sweden).
Why should you hire OIM for your upcoming MEDTECH project?
Among other things, we will help you with the following:
Concept study
Develop a concept or feasibility study
Design sketch
We create a product visualization made in 3D or design sketch
Proof of Concept
Technology choice and functional feasibility
Product development
Design and prototyping in and iterative process
Verification & Validation
Verification and validation of technical and user requirements
Production
Small-scale series production
Our services
Product development
OIM uses a certified product development process, where we guide our customers through all the steps from idea to product ready for launch, all in a quality-conscious way.
OIM has a rich legacy of running product development projects in-house and our ISO 13485 guarantees quality and structure.
Joint Businesses
Almost every customer or project that we collaborate with sees new possibilities and that is something we support and have a business model for.
Joint Businesses are a great way to use current ideas in current projects to create innovations. Some of the ideas even can become a whole new business case. Try us out!
ISO 13485-certification for MedTech product development
ISO 13485 is a standard for quality management that applies to medical devices. The standard is based on ISO 9001 but has higher requirements for formal documentation and specific requirements for product safety. Certification according to ISO 13485 makes it easier for companies by meeting customer needs while meeting the legal requirements that exist for the manufacture of medical products.
We have over 10 years of experience in developing products in MedTech sector
Some of our MedTech projects
TINNITUS-TREATMENT
Industrial Design
Product Development
CE-marking
Mechanical Design
Electronics Design
Quality Assurance
Tinearity will be the world’s first and smallest medical technology classified product, exclusively intended for the treatment and relief of Tinnitus, regardless of the time of day. OIM was given the task of making all steps in product development from industrial design to finished product and CE marking. The product is expected to be launched on the market in 2023.
HEAD TRAUMA FIRST AID
Mechanical Design
Electronics Design
Injection Molding
Technical documentation
CB Certification
Within contact sports such as Ice Hockey or American Football, concussions occur frequently. PolarCool has developed a system to reduce the risks of permanent damage and shorten the rehabilitation period by delivering first aid on-site. OIM was chosen as a product development partner for all necessary steps within product development, productizing a prototype to a finished product that meets the Medical Device Regulation and fulfills the IEC 60601-1 standard.
PROSTATE TREATMENT
Industrial Design
Product Development
Mechanical Design
Electronics Design
Software Development
Electric Safety
Technical documentation
Production
ProstaLund is a Swedish medical technology company, a leader in the development of innovative products and treatments in urology. ProstaLund has developed CoreTherm®, an individualized heat treatment for benign prostate enlargement. CoreTherm® is used today in hospitals and doctor’s surgeries in Sweden and around the world. The assignment for OIM included developing a modernization and development of the next generation of products that are fit for the market. OIM was responsible for implementing all functionality, with the ultimate goal that it must meet the regulatory requirements and ultimately be CE marked. OIM will also handle the upcoming production of CoreTherm®.
Want to see more cool reference projects?
More projectsQuality assurance and ISO certification
For us, strict requirements and regulations together with solid quality assurance are an extremely important component when working in the MedTech area. With our ISO 13485 certification, we cover both development and production in Life Science. We are used to working on technology-heavy projects where streamlining and tight schedules are decisive factors.
We have expertise in all necessary disciplines such as mechanics, industrial design, electronics, software, hardware, QA, and production technology.
Some of the people behind the MedTech company OIM
Our offering ranges from innovative product development, and joint project commitment to raising capital, which means that we become a business development partner to the customers we work with. Contact our MedTech team for help with innovative solutions for your medical devices:
Want to know more about OIM Sweden?
Feel free to contact us at +46 40-13 13 69 or fill out the form and we will get back to you as soon as possible!