Predictable Medical Device Development
Development process aligned with FDA, ISO, MDR Requirements
Developing a medical device involves a lot more than just having a design and a physical prototype. McDougall has the proven capability to plan and execute The FULL device development process aligned with FDA, ISO, MDR requirement to take your concept/your design and refine, verify and validate it, while at the same time creating your full Design History File, completing your regulatory clearances, and qualifying your manufacturing process for a smooth transition into commercialization. We take on as much or as little of the development as desired and work closely with our clients throughout the process.
Please contact us at info@mcdougallmedtech.com. We are excited to learn about your device and prepare a comprehensive plan for you to complete your device development.
Medical Specialties:
- Peripheral Vascular
- Vascular General
- Orthopedics
- Trauma
- Neurovascular
- Cardiology
- GI
- Robotic Surgery
- ENT
Technical Specialties:
We are the solution to your technical device needs.
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- Mechanical Design
- Sterile Packaging Design
- Electro-Mechanical Capabilities
- Specialized Coverings (Electrospinning)
- Self-Expanding Implants
- Catheter Design
- Articulating End Effectors
- Contract Manufacturing
Get Started Today
Talent
- We can deploy a wide array of associates to support medical device development and manufacturing programs.
- Associates are trained to our FDA and ISO compliant Quality System.
Management
- Project Management
Marketing
- Product Marketing
Engineering
- Design Engineering
- Development Engineering
- Product Dev Technicians
Scientific
- Biomaterial Specialist
- FEA Specialist
- Statistician
- Microbiologist
- Sterilization Advisor
Business & Legal
- IP Attorney
Clinical, Quality & Regulation
- Regulatory Advisor
- Validation Engineering
- Quality Assurance
Operations
- Material Managment
- Line Lead / Operators
- Our model utilizes best-in-class systems for optimal Medical Device Development, Manufacturing and Distribution.
- FDA Registered
- ISO 13485 Compliant
- QSR Compliant
- EU MDR Compliant
Quality Systems
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- Design Controls
- Production and manufacturing
- Document Control
- Complaint Handling
- Control of Nonconforming Product
- Identification and Traceability
- Medical Device Reporting
- Purchasing/Supplier Controls
- Receiving Inspection
- Risk Management
- Distribution
- Statistical Techniques
- Tooling Control
- CAPA
- Equipment, Product and Process Validation
- Design Verification and Validation
Equipment / Facility Capabilities
McDougall MedTech has access to equipment to fulfill client needs for:
- Leak / Burst Testing
- Dimensional Inspection
- Testing for Other Physical Properties (kink testing, pouch peel, bubble testing, etc)
- Optical Inspection
Design Area
- CAD
- Machining
- 3D Printing
- Laser Cutting
- Prototyping
- Finite Element Analysis
Development Areas
- Material Testing
- Process Development
- Design Verification
- Low Volume Development
- High Volume Development
Operations Areas
- Receiving Inspection
- ISO class 8 Clean Room
- Controlled Component & FGI Storage
- QA Testing
- Validated Ethylene Oxide Sterilization Cycle
- Packaging & Labeling
Contact Us
For inquiries, please contact us at:
info@mcdougallmedtech.com
McDougall MedTech
1221 Stirling Rd Suite 109,
Dania Beach, Fl 33004