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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
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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.
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Engineering Analysis
Toltec offers medical device analysis for the following.
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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:
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Feasibility Analysis and Testing
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Planning and Requirements Development
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Conceptual Design and Analysis
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Detailed Design
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Prototyping and System Integration
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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
Toltec offers expert witness services for patent and product liability cases. Highly experienced medical device engineers are available in all engineering disciplines.
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