OEM - Creative Solutions to Meet Your Needs
With over 20 years’ experience, Surgical Innovations (SI) is an industry leader in offering OEM solutions to some of the largest medical device companies in the world. From concept design through to post-market, SI delivers a full service OEM product development and manufacturing partnership. Whatever your needs, challenges or ideas, SI’s expert team can find a solution customised to your needs.
Concept Design Prototyping
Our concept design team work with you to develop blue sky ideas according to individual customer requirements. The designers are put through the same core skills surgical training exercises as surgeons, allowing them to truly immerse themselves in the role of the end user. This includes rapid prototyping with use of a 3D printer.
Product Development Engineering
Our product development team take a working prototype from concept and manage your project through to production. This involves expert planning, refining designs to the highest standards ensuring they are effectively engineered for manufacture, and gaining clinical feedback every step of the way.
Licensing and Regulatory Services
Our medical devices comply with international standards and our regulatory team are always on hand to guide you all the way from submission to clearance, while also offering product support services. This includes:
- 510(K) submissions for FDA clearance
- EU technical file for CE marking approval
- All other international device approvals and registrations
Added Value Manufacture
SI’s in-house manufacture facility is made up of machine shop, assembly, clean room and injection moulding. Our state-of-the-art machinery allows us to produce expert precision-engineered products in close collaboration with our product design and quality teams. From small batch runs through to volume production, our manufacture and assembly teams ensure our devices meet exacting quality specifications.
Our communications experts are dedicated to helping you with all of your post-market needs. This includes your IFU, labelling and packaging requirements in addition to branding of the device itself.