Our Services, Your Successes
focus areas
Medical Device Pros, LLC provides engineering expertise for:
- Design and Development (From Idea to Reality: Drawings, Design of Experiments, Biocompatibility, more!)
- Regulatory Filings & Support
- Manufacturing-Related Services
- Crisis Mitigation (even 483 Troubleshooting!)
- Helping other Medical Device Consultants
Medical Device Design & Development Services
Invention, Feasibility - "Design My Medical Device right from the start!"
- Patent & TM Applications, including drawings
- Feasibility assessment for your project & upfront DoEs
- Safety & Materials selection: including Biocompatibility testing & Toxicological Risk Assessment
PROTOTYPES - "Let's build and test my idea!"
- Concept sketches and drawings
- Fabrication of prototypes done by or directed by an Engineering Consultant (for Silicone, specialty metal alloys, etc.)
- Testing to ASTM and ISO standards, or unique testing
ENGINEERING & PRODUCT DEVELOPMENT - "How can I make this better? More efficiently?"
- Design of Experiments (DoE) for medical device product design
- Customized testing and troubleshooting. Data analysis, graphing. Root cause analysis.
- Test method validation (TMV)
Regulatory Filings & Support Services
REGULATORY FILINGS - "How do I get this approved?"
- Medical Device classification guidance for a Class I, Class II, or Class III medical device or for a Cosmetic product, based on your specific invention, product design, or medical device
- U.S. (FDA) and International regulatory support
- Crisis Situation? Click Here.
Manufacturing-Related Services
MANUFACTURING - "HOW CAN I make this commercially?"
- Manufacturing Startup: process & package protocols, validations, DoE (Design of Experiments.)
- Scale-up: from prototypes to larger scale production. Crisis troubleshooting, 483s: Click Here.
- Global Equipment/Manufacturer recommendations and negotiations.
Crisis Mitigation Services
you need experienced support
you need experienced support
you need experienced support
Situations like receiving a 483 from FDA, an imminent product recall, a manufacturing shutdown, or COVID-19 supply issues require swift yet thorough action. You need a Pro.
data is critically important
you need experienced support
you need experienced support
To truly resolve a crisis such as a 483, thorough data gathering and analysis is critical. Medical Device Pros, LLC provides leadership and support.
COMMUNICATION IS KEY
you need experienced support
COMMUNICATION IS KEY
Medical Device Pros, LLC has been commended by clients for our effective yet diplomatic approach: with other consultants, company employees, and the FDA.
Services for Other Consultants
medical device pros, llc welcomes your inquiries
We have been part of the medical device industry for decades, and we understand its complexity. If your consulting firm needs engineering support, chances are that we can deliver it. And if we can't, we can usually guide you to the proper resource.
Other consultants have very recently called us about:
- Cardiology device development
- COVID-19 Emergency Use Authorizations for N95 and KN95 masks
- Silicone recommendations for a first-in-kind medical device
- Data analysis for complex 510k submission
- Design of Experiments
trusted partners
Medical Device Pros, LLC is a trustworthy partner--to our own Clients, and to our fellow Consultants as well. We will confidentially discuss your particular needs, and recommend a path forward.