ProMedic
ProMedic, LLC provides business development services to the medical device industry with a focus on moving ideas, concepts, and products to successful commercialization. They support the medical device industry, especially during the COVID-19 pandemic, by offering expertise in regulatory requirements, market viability, market entry, and business development. The company has a long-standing history since 1975 and aims to become a valued partner with each client, emphasizing trust and collaboration.
Industries
Nr. of Employees
small (1-50)
ProMedic
St. Petersburg, Florida, United States, North America
Services
Consulting to determine device classification and appropriate US regulatory pathway and preparation/management of 510(k), de novo, IDE, EUA and pre-submission activities; submission package preparation and FDA liaison.
Support for UDI program planning, FDA product-code mapping, GUDID account setup, data collection and web-based data entry, barcode implementation and verification/validation.
Execution of establishment registration, device listing, annual renewals and acting as designated US agent for foreign manufacturers to facilitate FDA communications and inspections.
Development and implementation of compliant QMS (ISO 13485/MDSAP/CMDR/MDD/QSR), internal audit programs, procedural writing, staff training, and remediation of regulatory findings.
Device classification for EU requirements, technical file and design dossier preparation, notified body selection support, declaration of conformity and labeling review.
Assistance with device classification, establishment registration consistent with ISO 13485/CMDCAS and obtaining Canadian device licenses.
Consulting to determine device classification and appropriate US regulatory pathway and preparation/management of 510(k), de novo, IDE, EUA and pre-submission activities; submission package preparation and FDA liaison.
Support for UDI program planning, FDA product-code mapping, GUDID account setup, data collection and web-based data entry, barcode implementation and verification/validation.
Execution of establishment registration, device listing, annual renewals and acting as designated US agent for foreign manufacturers to facilitate FDA communications and inspections.
Development and implementation of compliant QMS (ISO 13485/MDSAP/CMDR/MDD/QSR), internal audit programs, procedural writing, staff training, and remediation of regulatory findings.
Device classification for EU requirements, technical file and design dossier preparation, notified body selection support, declaration of conformity and labeling review.
Assistance with device classification, establishment registration consistent with ISO 13485/CMDCAS and obtaining Canadian device licenses.
Expertise Areas
- Regulatory strategy and submissions (510(k), de novo, IDE)
- UDI compliance and GUDID data submission
- Quality management systems and ISO 13485 implementation
- CE marking and EU technical file preparation
Key Technologies
- GUDID / UDI data submission and barcode implementation
- ISO 13485-based QMS
- 510(k)/de novo/IDE regulatory submission processes
- Design verification & validation (DV/IV) and IQ/OQ/PQ
News & Updates
ProMedic hires Nichole Leahy-Glass, a specialist in Quality Management Systems with extensive experience in the medical device industry.
ProMedic participated in the 2017 Florida Medical Device Symposium, showcasing their services.
Paul Dryden, President of ProMedic, authored an article exploring regulatory paths for TCI in the US.
FDA launched a publicly available database for device identification, with support from ProMedic.
ProMedic hires Nichole Leahy-Glass, a specialist in Quality Management Systems with extensive experience in the medical device industry.
ProMedic participated in the 2017 Florida Medical Device Symposium, showcasing their services.
Paul Dryden, President of ProMedic, authored an article exploring regulatory paths for TCI in the US.
FDA launched a publicly available database for device identification, with support from ProMedic.