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Medical Device Engineering Services  Product Development 
 FDA Compliance Services

Engineering & Medical Device Compliance Services

Toltec is ready to assist your development needs in four basic service areas.  These service areas are described below.

Medical Device Engineering Consulting Services

Our engineering consulting services enable your company to obtain experts in the multiple engineering disciplines needed for medical devices.

Engineering Consulting Disciplines                        Medical device engineering consulting in all major disciplines.
 Systems Engineering
Software Engineering
Mechanical Engineering
Electrical Engineering
Project Management
Manufacturing Process Development

Engineering Analysis 
Toltec offers medical device analysis for the following.

 Risk Analysis
Expert Witness
FMEA Analysis
Fault Tree Analysis

Contract Medical Device Product Development Services

This service is for companies which are requiring development for an item and do not have the resources, time or budget to enable a cost effective solution to development needs. Using this service, Toltec will provide a "turn-key" solution to your engineering and development needs.  We offer services in all of the typical product development project phases:

  1. Feasibility Analysis and Testing
  2. Planning and Requirements Development
  3. Conceptual Design and Analysis
  4. Detailed Design
  5. Prototyping and System Integration
  6. Validation and Verification Testing

Design Control and Medical Device Submission Services

Toltec offers medical device design control services related to complying with cfr 820.30 and ISO 13485.  Toltec also provides services to get your FDA 510k or PMA submission completed.  Toltec is unique in the sense that we do more that consult.  We will provide resources that create the finished documentation if that is what you require. 

 FDA Submissions
 Design Control

 Risk Analysis 

 Validation and Verification

      Expert Witness and Analysis Services

    Toltec offers expert witness services for patent and product liability cases.  Highly experienced medical device engineers are available in all engineering disciplines.

    Copyright 2006 Toltec International, Inc. All rights reserved.

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