Medical Devices and Instrumentation

Sage Design fully understands the regulated environment of medical devices and medical instrumentation.  We have designed and built to meet the requirements of the US FDA and the European Union CE mark and other governing bodies and have guided products through the approval procesess.

In coordination with our design efforts, we have developed and conducted clinical trials on both instrumentation and devices that fall into the FDA categories of Class I and Class II and have applied for and been granted 510(k) approvals.

The majority of our designs include embedded microprocessors and we fully support the needed documentation trail and software testing needed to obtain approvals and maintain these approvals over time.

Our design efforts range from stand-alone battery and mains powered instrumentation - both portable and fixed designs.  Our portable designs fit into the categories of either transportable or hand-held.

With any regulated products, documentation is as critical a factor as is the design itself.  Sage design maintains fully compliant document controls to assure regulatory approvals.

Sage Design fully understands the regulated environment of medical devices and medical instrumentation.  We have designed and built to meet the requirements of the US FDA and the European Union CE mark and other governing bodies and have guided products through the approval procesess.

In coordination with our design efforts, we have developed and conducted clinical trials on both instrumentation and devices that fall into the FDA categories of Class I and Class II and have applied for and been granted 510(k) approvals.

© Sage Design, Framingham, MA, USA - 2014

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