Sterling Medical Devices products

In the general perspective, product design necessitates that your product can fundamentally work for its purpose, be aesthetically well received by its users, and be economically manufactured with cost-effective materials. However, the high-quality demands of industry markets can become a challenge when approached independently. Sterling’s medical device industrial design consultations offer an in-depth understanding of the dynamics of the industry. We provide our clients with the opportunity to express their vision through their products.

Prototyping is a learning process and trials must be done diligently with attention to detail to avoid extraneous costs that might hinder the product from reaching market mass production. During this time, hundreds of exact replicas may be needed to verify and validate a design. Without proper management, redesigns can become a burden with each respective batch that needs to be reworked. Sterling Medical Devices walks clients through the design process-from sketches to 3D models to the prototyping stage. Sterling identifies medical prototypes not only as a necessary requirement to move from proof of concept to a physical product, but also to test with your customers in the clinical environment.

Medical product design is a crucial phase in the product development lifecycle. A mix of art and science, the design of life-improving medical devices that align with healthcare regulatory requirements and meet end-user needs is a complex process that requires innovation, precision, and advanced expertise.

All medical devices sold in the EU must have a Clinical Evaluation Report (CER) as part of its technical documentation to satisfy the new EU Medical Device Regulation (MDR) requirements. A comprehensive analysis of pre- and post-market data relevant to a medical device, a Clinical Evaluation Report demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.