McDougall MedTech
Welcome to McDougall MedTech
Your comprehensive solution for
Medical Device Design, Development and Contract Manufacturing services.
•Adhoc Engineering, Regulatory Consulting
•Full Product Development
•Contract Manufacturing
McDougall MedTech is an FDA registered medical device design, development and manufacturing service provider.
We provide the engineering, quality and regulatory resources, quality systems, and equipment/facility capabilities to complete your full medical device product development and contract manufacturing across a variety of different medical specialties.
MedTech Design and Development
Contract Manufacturing
Capabilities, Historical Successes
McDougall MedTech offers access to tenured device development professionals, with a breadth and depth of knowledge across numerous medical specialties. Our experts have many years of combined experience in developing and commericalizing medical devices.
Below is a snapshot of our capabilties and historical successes.
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Multiple successful submissions with FDA and 510k clearances
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Successful tech file submissions and audits for CE mark in EU
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1000s of units built for Contract Manufacturing clients with high yield
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100s of prototype designs developed and refined
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100s of test methods and fixtures developed
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100s of units tested for design verification
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100+ Animal and physician labs conducted for design validation
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Biocompatibility strategies developed, and testing executed meeting ISO and FDA requirements
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EO Sterilization validation and adoption conducted for multiple products
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Sterile packaging developed and tested according to ISO/ASTM/FDA reqs
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Transportation and environmental conditioning strategies developed, and testing executed meeting all ISO/ASTM/ISTA/FDA reqs
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Electrical safety testing plans/strategies developed, and testing conducted to ISO 60601