Orthopedx is a division of Devicix LLC. Devicix is an ISO 13485 (design) and ISO 14971 (risk) certified design firm. Outsourcing a design or task to our team, comprising professionals with advanced degrees and decades of medical device and orthopedic design, gives our clients the ability to focus on their business, technology and new designs. Combinung cutting edge design, quality, safety and reliability, our engineers provide comprehensive design services for the orthopedic industry.

 

Whether you are a surgeon inventor, a university, entrepreneur or multinational orthopedic OEM, you will appreciate te fact that Orthopedx is committed to the highest level of quality. Product quality, compliance to all applicable regulatory requirements, continuous improvement and customer satisfaction motivate all of our efforts. Our quality capabilities have grown over time to meet our customer needs.

 

Requirements and Standards

• We use an ISO 13485 certified quality system for design control

• We use a validated electronic document control system

• We use an ISO 14971 certified  processes and are experts in human factors (HE 75, ANSI 62366).

• IEC 60601 and IEC 62304 expertise for those complex powered devices such as navigation and robotics.

• Manufacturing capabilities to support pilot and smaller productions builds (< 10k/yr)

• History of complying to other quality systems without additional support