Provides business development services
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
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
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
Pre-submission
QA / RA Consulting
QA / RA support for domestic and international Standards and regulations
De novo petitions
IDE
Pre-submission
QA / RA Consulting
QA / RA support for domestic and international Standards and regulations
De novo petitions
IDE
Unique Device Identification (UDI)
Regulatory support
UDI compliance and implementation
Data collection
GUDID account registration
Web-based Data Entry
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
Device Listings
US Agent
483 and Warning Letter mitigation
Business Development
Market research
Clinician utility assessments
Facility relocation
Licensing
Merger and Acquisition
Marketing and Distribution relationships
Clinician utility assessments
Facility relocation
Licensing
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
Cardiovascular
Dental
Gastroenterology
General Hospital
Kits and Trays
OB/ GYN
Orthopedic
Surgical Instruments
Urology
Cardiovascular
Dental
Gastroenterology
General Hospital
Kits and Trays
OB/ GYN
Orthopedic
Surgical Instruments
Urology
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…Read MoreFMMC 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…Read MoreTarget-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…Read More