Quality Systems for Medical Devices

ISO 13485

Dedicated Computing has been audited and certified for ISO 13485. This is the quality standard, similar to ISO 9001:2008, which applies specifically to medical devices. As a result, we are able to manufacture compute engines for use in OEM medical devices, and to ship the compute engine directly to the end-user.

This capability provides a unique value to OEM medical customers. Customers are freed from performing required final test and verification processes at their own site -- and may even be freed from having to operate their own manufacturing facility.

Dedicated Computing provides end-user fulfillment for Class I and Class II devices, and provides manufacturing services for Class III devices.

We are FDA Registered.

Our quality system and procedures are consistent with FDA Current Good Manufacturing Practices (CGMP) Title 21 Part 820 of the Code of Federal Regulations. Our CGMP services include Device History Records (DHR), Device Master Records (DMR) and Correction Action/Preventative Action (CAPA) documentation.

How does this relate to non-medical products?

Product and process quality is one of our core values, and high quality products and processes provide maximum profit opportunities for OEM customers regardless of their markets.

We have already received ISO 9001:2008 certification, as well as various technology specific validations such as operating system validation Microsoft WHQL, RedHat and SuSE system and personnel certifications.