Product
Development

Verification
Validation

Consulting &
Training

Intertech Engineering Associates, Inc. is a Massachusetts corporation that provides a variety of services to the medical device industry from our facility in Westwood, Massachusetts. Our services help our clients in developing and validating their products, managing their projects, and in building their own internal expertise. Our client base is both national (US) and international.

Our focus on the medical device industry makes us very aware of the regulatory challenges our clients face in designing, developing, and validating new products.  The application of our experience and expertise in software and electronics engineering to medical device design is tempered by the awareness of our clients' regulatory needs. 

We are also leaders in the validation of software used to automate processes related to the design or manufacture of medical devices, or any other aspect of the quality system (21 CFR 820.70i)

• Intertech's President Honored
David Vogel was named as one of the "100 Notable People in the Medical Device Industry" by MD&DI Magazine.  More...

• "Streamlining Your Company's Design Control SOPs"
This topic will be addressed at the 5th Annual Medical Device Quality Congress on June 27.  More...

 • SoftwareCPR Offering Course on "Efficient Use of Medical Device Software Standards"
This new course will be held September 15-17 in the Boston area.  More ...

• Intertech Announces New Technology Partnership Program
Dolomite Microfluidics is the first partner in this program.  More ...

AAMI TIR36:2007 Validation of Software for Regulated Processes
Will be available from AAMI on or before March 19.
More ...

• Library Updates!
Check out the Library link.  We've added several new FDA documents related to software.  Another eight periodical reprints authored by Intertech employees have also been added.

• We've Moved
Our new address is 100 Lowder Brook Drive, Suite 2500, Westwood, MA  02090.  Our new main phone number is 781-801-1100 and our fax number is 781-801-1108.  Directions ...

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