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)

New Textbook Released!Medical Device Software: Verification and Validation and Compliance has finally been published!  See Details or Purchase here...

• We're Hiring Again!
Intertech is hiring software, quality, and compliance professionals.  Opportunities exist for embedded and mobile platform developers, SQA engineers, and consultants for Safety Assurance Case and "3rd edition" compliance.  Send your resume and salary requirements to resumes@inea.com.

• AAMI Workshop
AAMI has contracted Intertech to create a workshop on Software Validation.  This workshop is based on the textbook written by David Vogel.  Public workshops are scheduled in May and October 2012.  Click here for details. 

• FDA Announces
Draft Guidance for Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies.
Download a copy here.

• 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.

• 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...

• Intertech Opens New Office in Illinois
Intertech has leased almost 4,000 sq. ft. of office space in Lincolnshire, IL to establish a more local presence for our Midwest clients. More information to follow.

• We Moved ... in 2007!
If you haven't been here for a while, our new Boston area 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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