Welcome to McDougall MedTech
Your comprehensive solution for:
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- Medical Device Design and Development
- Medical Device Contract Manufacturing
- Adhoc Engineering, Quality and Regulatory Consulting
Call (786) 281-8477
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.
Our Services
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.
- Multiple successful submissions with FDA and 510k clearances
- Successful tech file submissions and audits for CE mark in EU
- 1000s of units built for Contract Manufacturing clients with high yield
- 100s of prototype designs developed and refined
- 100s of test methods and fixtures developed
- 100s of units tested for design verification
- 100+ Animal and physician labs conducted for design validation
- Biocompatibility strategies developed, and testing executed meeting ISO and FDA requirements
- EO Sterilization validation and adoption conducted for multiple products
- Sterile packaging developed and tested according to ISO/ASTM/FDA reqs
- Transportation and environmental conditioning strategies developed, and testing executed meeting all ISO/ASTM/ISTA/FDA reqs
- Electrical safety testing plans/strategies developed, and testing conducted to ISO 60601
Contact Us
For inquiries, please contact us at:
info@mcdougallmedtech.com
McDougall MedTech
1221 Stirling Rd Suite 109,
Dania Beach, Fl 33004