D2 Realization has extensive experience in creating medical devices as well as experience in taking those products through both the FDA and European Device certification process. Medical devices we have designed are currently being sold worldwide.
D2 Realization Inc. and our team is also proud to have been recognized by the San Diego Business Journal as finalists for the San Diego Business Journal’s Innovation Awards for our medical device work.
Bringing a medical product to market can be a challenging task. It is important to keep knowledge of the FDA requirements and European 60601 medical device standard often in mind and engage early in processes that documents the design inputs and outputs so there is complete development file in place when applying for FDA approval. Due to these extra documentation requirements, it is important to employ designers and engineers that have experience in this process.
Once designed and approved, medical devices sold in the United States need to also be manufactured and produced in FDA approved manufacturing facilities. Over the years we have partnered with several FDA approved manufacturing facilities, to bring products past design and development and into continuous manufacturing for our clients. Several of these medial manufacturing companies were so happy with our work they have come back to us to work on projects for other clients of theirs or have referred other business to us.
Medical Devices our team has worked on include:
-Digital Ophthalmic Cameras
-Non-invasive Glucose monitors
-Ocular autoflorescence scanners
Medical Related Laboratory products our team has worked on include:
-Automated blood typing machines