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: Q-sub, 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)
Global device registration
Labeling and promotional review
UDI System strategy, registration, & management
Post-Market Surveillance and reporting
Response to regulators (e.g., FDA 483 and FDA or NB audit findings) including planning and execution of remediation

Training

Training for Regulatory Affairs and Quality Assurance departments :

process and procedures (including development and updates to 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
Recall strategy, regulatory communication, and recall execution