Medical Device Pros
Engineering consultancy focused on medical device development, regulatory support, materials selection, testing, and manufacturing scale-up. The firm provides design-to-launch services including prototype fabrication, statistical data analysis for regulatory submissions, crisis mitigation (FDA 483 and recall support), and materials/coating process expertise.
Industries
Nr. of Employees
small (1-50)
Medical Device Pros
Satellite Beach, Florida, United States, North America
Products
Engineering Consulting for Medical Devices
Provides engineering consulting services for design, development, manufacturing support, and troubleshooting of medical devices across all device classes.
Crisis Mitigation Services
Provides leadership and data-driven support to resolve regulatory and manufacturing crises such as FDA 483 letters, corrective actions, and product recalls.
Medical Device COVID-19 Services
Offers consulting to help inventors and manufacturers of COVID-19 related medical supplies and devices meet FDA and NIOSH requirements for market readiness.
Engineering Consulting for Medical Devices
Provides engineering consulting services for design, development, manufacturing support, and troubleshooting of medical devices across all device classes.
Crisis Mitigation Services
Provides leadership and data-driven support to resolve regulatory and manufacturing crises such as FDA 483 letters, corrective actions, and product recalls.
Medical Device COVID-19 Services
Offers consulting to help inventors and manufacturers of COVID-19 related medical supplies and devices meet FDA and NIOSH requirements for market readiness.
Services
Design and development consulting
Feasibility assessment, invention support, drawings, DoE, and product development for Class I–III devices and combination products.
Prototype fabrication and testing
Prototype direction or fabrication, including silicone and specialty alloy prototypes and customized testing up to pilot scale.
Regulatory filings and submission support
Guidance on device classification and preparation/support for FDA and international submissions, including support during emergency or crisis scenarios.
Crisis mitigation services
Rapid leadership and technical support for manufacturing or regulatory crises such as FDA 483 responses, recalls, or supply disruptions.
Materials selection and coatings consultancy
Materials recommendations for device performance including silicone composites, polymer coatings, carbon nanotube composites, and specialty fluids.
Design and development consulting
Feasibility assessment, invention support, drawings, DoE, and product development for Class I–III devices and combination products.
Prototype fabrication and testing
Prototype direction or fabrication, including silicone and specialty alloy prototypes and customized testing up to pilot scale.
Regulatory filings and submission support
Guidance on device classification and preparation/support for FDA and international submissions, including support during emergency or crisis scenarios.
Crisis mitigation services
Rapid leadership and technical support for manufacturing or regulatory crises such as FDA 483 responses, recalls, or supply disruptions.
Materials selection and coatings consultancy
Materials recommendations for device performance including silicone composites, polymer coatings, carbon nanotube composites, and specialty fluids.
Expertise Areas
- Medical device design and development
- Regulatory compliance and submission support
- Manufacturing scale-up and process validation
- Materials engineering and polymer coatings
Key Technologies
- Design of Experiments (DoE)
- 3D printing / rapid prototyping
- Polymer coating processes
- Supercritical fluid coating