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Medical Device Pros, LLC

Medical Device Pros, LLCMedical Device Pros, LLCMedical Device Pros, LLC

Medical Device Pros, LLC

Medical Device Pros, LLCMedical Device Pros, LLCMedical Device Pros, LLC
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1-321-210-5633


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COVID-19

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Our Services, Your Successes

focus areas

medical device consultant monitoring test results

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

patent, intellectual property, project feasibility

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

See Examples
prototype mold by machining aluminum or stainless steel

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

efficient product development diagram

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) 

See Examples

Regulatory Filings & Support Services

regulatory compliance

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 equipment

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.

See Examples

Crisis Mitigation Services

emergency crisis

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.

consultants working

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.

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crisis communication by telephone

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.

Call Us Today

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