RCB Regulatory Affairs Services - Medical Devices and IVDs
Strategic Planning
Analyses and Recommendations to Meet Your Regulatory Needs
We provide Regulatory Affairs planning that ensures optimization of
regulatory submissions
promotional communications
brand strategies - we help ensure that marketing is planned in accordance to regulatory requirements
that fit your Company's specific needs for long-term regulatory compliance
Deliverables
Global Regulatory Affairs Submissions and Regulatory Communications
FDA - IDE, 510(k), PMA, and De Novo submissions
Establishment and Maintenance of CE Marks: Tech Files, Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up Reports (PMCF)
Navigation of global device registration (FDA, EUDAMED, etc.)
Labeling and promotional review
UDI System strategy, registration, & management
Post-Market Surveillance and reporting
Response to regulators, including planning and execution of remediation
Global Recall Coordination
Management
We offer management of Regulatory Affairs and Quality Assurance departments with a focus on:
training
process and procedures (including the QMS)
complaint intake, handling, and recording
long-term regulatory compliance
Additional Services
Planning and Execution of Regulatory Strategy
Regulatory planning and long-term strategy
Remediation planning and execution
Corporate and Stakeholder communications