ProMedic offers QA/RA Consulting that include ISO 13485:2016, ISO 9001, International Registrations / Licensing and FDA / QSR support. Check our list of services. Call us today to discuss your needs.

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ProMedic, LLC provides business development services to the medical device industry.

Our goal is to move ideas, concepts, and products to successful commercialization. During this time of the novel coronavirus/COVID-19 pandemic we are here to support the medical device industry in its efforts to supply much needed resources around the world.

Regulatory Requirements

FDA 510(k) clearances
Emergency Use Authorization (EUA)
de novo submissions
Unique Device Identification (UDI)
Foreign manufacturer needs
FDA US agent services
Health Canada registration

Market Viability

Market research to assess commercial viability.

Market Entry

Best method and options to market entry
License or market the product
Strategic marketing and distribution method

How we help

Since 1975 we have been active in the medical device industry where we can bring our expertise to you along with our vast network of resources for almost any project. Not all clients need all of these services but to reach success one must address all of these at some point. ProMedic prides itself in becoming a valued partner with each client, whether the project is large or small.

We believe in the time-honored tradition of – Always with a Handshake.

Areas of Expertise

FDA Regulatory strategies and clearances

510(k) for all types of devices
QA / RA Consulting
QA / RA support for domestic and international Standards and regulations
De novo petitions

Unique Device Identification (UDI)

Regulatory support
UDI compliance and implementation
Data collection
GUDID account registration
Web-based Data Entry

FDA Support

Establishment registration
Device Listings
US Agent
483 and Warning Letter mitigation

Business Development

Market research
Clinician utility assessments
Facility relocation
Merger and Acquisition
Marketing and Distribution relationships

Health Canada

Device classification
Registration Establishment Licensing
Device Licensing

CE Marking

Device classification
Technical files
Notified body / Authorized Reps
QMS MDD compliance

Product Areas Partial List

Anesthesia / Respiratory
General Hospital
Kits and Trays
Surgical Instruments

Recent News

  • ProMedic Announces New Hire
    ProMedic is pleased to announce the hire of Nichole Leahy-Glass. Nichole provides technical consulting services in Quality Management Systems. During her career, she has had several specific roles throughout the…
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  • FMMC Annual Symposium – ProMedic Exhibiting
    The 2017 Florida Medical Device Symposium will be held May 8-9, 2017, at the Hilton Carillon Park in St. Petersburg. The symposium is Florida's premier event for medical device manufacturing…
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  • Target-Controlled Infusions: Paths to Approval
    Recently, Paul Dryden, President of ProMedic, authored an article regarding TCI. The purpose of this special article is to explore possible regulatory paths that could lead to TCI marketing clearance…
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