Medical Device Manufacturing

Faced with the high cost of establishing own production facility or inability of the existing limited physical plant to meet the increasing demand, more and more medical device companies choose to cooperate with device manufacturers. According to the requirement of ISO 13485 standard and Good Manufacturing Practices (cGMP), SETMart provides regulation compliant manufacturing service to help customers decrease manufacturing costs while maintaining product quality, compliance, intellectual property protection, and patient satisfaction.

According to FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices”, it is important to adopt human factors engineering processes in the design and manufacturing of medical devices for enhancement of patient safety. In addition, physical ergonomics shall be concerned in the design of user interface (UI) to reduce the risk of work-related musculoskeletal injuries and illness. STEMart provides expert Ergonomics and Human Factors Analysis for medical device to ensure that people can use this medical device efficiently and safely.

7-6-Medical-Device-Manufacturing-1 Fig. 1 Device user interface in operational context. (Gray, 1997)

Medical Device Manufacturing

Class Ⅰ, Ⅱ & Ⅲ Medical Device Manufacturing >

As a compliant, competent, and competitive medical device contract manufacturing partner, STEMart provides on-stop design and manufacturing solution for Class Ⅰ, Ⅱ and Ⅲ medical device, including complete design engineering covering the entire product development cycle, validation and verification according to product functional, performance and safety requirement, and mass production.

Global Sourcing >

STEMart provides global sourcing of medical devices and supplier auditing for quality manufacturing in compliance with ISO13485 standards and environmental regulations.

Ergonomics and Human Factors Analysis >

According to standards associated with ergonomics released by American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), as well as IEC 62366 and FDA guidance, STEMart provides a series of ergonomics and human factors analysis service for medical device to reduce human error, increase productivity, and enhance safety and comfort with a specific focus on the interaction between the human and medical device. Services include:

Identification of user, use environment, user interfaces and critical task
Use-related risk assessment
User interface design
Formative evaluation
Usability testing
Summative validation testing
Residual risk analysis

STEMart provides medical device manufacturer with regulation compliant manufacturing service, a global sourcing solution and complete ergonomics and human factors analysis. If you want to learn more detail about our medical device manufacturing service, or would like to consult with the experts at STEMart, please feel free to contact us.

Reference

FDA Human Factors Guidance, 2016, pg 6
Gray, M, et al. "Human factors in safety-critical systems." Journal of Hazardous Materials 56(1–2):218 (1997) .

Medical Device Manufacturing

Medical Device Manufacturing

Class Ⅰ, Ⅱ & Ⅲ Medical Device Manufacturing >

Global Sourcing >

Ergonomics and Human Factors Analysis >

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