ProMedoss
Consulting firm supporting medical device startups and entrepreneurs to bring devices from concept to market. Services focus on regulatory strategy and submissions, clinical trial design and operations, quality management system (QMS) establishment and compliance (ISO 13485/QSR), due diligence and market/regulatory assessments, and tailored training and representation services for US and EU regulatory processes.
Industries
Nr. of Employees
small (1-50)
ProMedoss
Products
Submissions to Regulatory Agencies
Assistance in compiling submissions to various regulatory agencies including 510(k), PMA, IDE, and pre-sub packages.
Development of Regulatory Strategies
Comprehensive regulatory strategy services including brief localized opinion letters or multi-market regulatory strategies to help secure funding and understand resource requirements.
US Agent Services
Acting as a US Designated Agent for foreign companies with no local representation and assisting in registration and listing of devices with the FDA.
QMS ComplianceSupport
Comprehensive quality management system compliance and support services for medical device manufacturers, including ISO 13485 and QSR compliance, audits, gap analysis, and FDA inspection representation.
Implementing of Regulatory Requirements
Services to stay on track with regulatory plans, locate third-party laboratories, design device-specific testing, and manage clinical studies.
Person Responsible for Regulatory Compliance (PRRC) Services
Serving as the Person Responsible for Regulatory Compliance (PRRC) for micro and small enterprises per European MDR requirements.
Submissions to Regulatory Agencies
Assistance in compiling submissions to various regulatory agencies including 510(k), PMA, IDE, and pre-sub packages.
Development of Regulatory Strategies
Comprehensive regulatory strategy services including brief localized opinion letters or multi-market regulatory strategies to help secure funding and understand resource requirements.
US Agent Services
Acting as a US Designated Agent for foreign companies with no local representation and assisting in registration and listing of devices with the FDA.
QMS ComplianceSupport
Comprehensive quality management system compliance and support services for medical device manufacturers, including ISO 13485 and QSR compliance, audits, gap analysis, and FDA inspection representation.
Implementing of Regulatory Requirements
Services to stay on track with regulatory plans, locate third-party laboratories, design device-specific testing, and manage clinical studies.
Person Responsible for Regulatory Compliance (PRRC) Services
Serving as the Person Responsible for Regulatory Compliance (PRRC) for micro and small enterprises per European MDR requirements.
Services
Regulatory strategy development, regulatory testing coordination, submission compilation and agency interaction for device market entry.
End-to-end clinical trial support including project management, site monitoring, investigator recruitment, EDC/data management, IRB handling and AE/SAE reporting.
QMS establishment, SOP and documentation development, internal and mock audits, gap analyses and inspection representation to support ISO 13485 and QSR compliance.
Objective audits and assessments of regulatory and market status to evaluate feasibility, risks and commercial potential for investments, mergers or acquisitions.
Acting as a US Designated Agent for foreign companies and providing EU MDR PRRC services for small enterprises.
Customized training sessions on regulatory affairs, quality assurance, clinical operations and company-specific QMS procedures delivered on-site or online.
Regulatory strategy development, regulatory testing coordination, submission compilation and agency interaction for device market entry.
End-to-end clinical trial support including project management, site monitoring, investigator recruitment, EDC/data management, IRB handling and AE/SAE reporting.
QMS establishment, SOP and documentation development, internal and mock audits, gap analyses and inspection representation to support ISO 13485 and QSR compliance.
Objective audits and assessments of regulatory and market status to evaluate feasibility, risks and commercial potential for investments, mergers or acquisitions.
Acting as a US Designated Agent for foreign companies and providing EU MDR PRRC services for small enterprises.
Customized training sessions on regulatory affairs, quality assurance, clinical operations and company-specific QMS procedures delivered on-site or online.
Expertise Areas
- Regulatory strategy and submissions
- Clinical trial management and monitoring
- Quality management systems (ISO 13485/QSR) implementation
- Preclinical and clinical study design
Key Technologies
- Electronic data capture (EDC) systems
- Clinical trial monitoring and site management processes
- Regulatory submission frameworks (510(k), PMA, IDE, pre-sub)
- Quality Management Systems (ISO 13485, QSR)
News & Updates
Founder received the Richard E. Greco Award from the Regulatory Affairs Professionals Society in recognition of contributions to regulatory affairs.
Founder received the Richard E. Greco Award from the Regulatory Affairs Professionals Society in recognition of contributions to regulatory affairs.