Medical Device Development

We take a well-documented design-build-test approach in developing new medical devices. We ensure that our design inputs and product specs are in-place before spending excessive time in the details. When our designs are complete and our prototypes are built we evaluate each of the design inputs to understand the device status. This approach blends best practices in engineering with an efficient FDA ISO 13485 compliant development process.

We have experience developing devices for minimally-invasive surgery, orthopedics, in-vitro fertilization, gynecology, radiology, audiology, ENT, hematology clinical applications. We are skilled in the up-front translation of clinical needs into device specifications through the downstream engineering execution, prototyping and device manufacturing activities.

Medical Device Development Throughout the process we assess product safety, using tools such as dFMEA, and apply the features and functionalities needed to ensure a safe and effective device. Additionally, we continuously monitor development risks, build contingency plans in order to ensure rapid time to market.

Competencies

Laparoscopic / Minimally Invasive Surgical (MIS) Devices
Electrosurgical Devices
Colorectal Stapling Devices
In-Vitro Fertilization Devices
Hysterectomy Devices
Patient Thermal Management Systems
Orthopedic Implants and Deployment
Diagnostic Instruments
Hematology Devices
Drug Delivery Devices
Class II Medical Devices
Design Controls