Library

Webinars

Practical Approach to UDI Implementation PDF (Sept 23, 2015)

BIMO Readiness – Top 10 Useful Tips PDF (Nov 5, 2014)

Practical Guide to CER Preparation PDF (Feb 18, 2014)


White Papers

Predicting and Achieving Clinical Study Enrollment

Clinical Study Budgets

FDA Inspection Trends

Human Factors and Usability in Medical Devices

Patient Registries


Additional Resources

Procedures for Handling Section 522 Post-Market Surveillance Studies

Procedures for Handling Post-Approval Studies Imposed by PMA Order

FDA Guidance Manual for Sponsors CROs and Monitors 7348.810

FDA Guidance Manual for Clinical Investigators 7348.811


Industry Resources

American Society for Quality (ASQ)

American Statistical Association

Association of Clinical Research Professionals (ACRP)

European Medicines Agency (EMA)

Food and Drug Administration (FDA)

International Organization for Standardization (ISO)

Medical Alley

Mass Medic

Medical Device Resource Group (MDRG)

Orange County Regulatory Affairs (OCRA)

Regulatory Affairs Professionals Society (RAPS)

Society for Clinical Data Management (SCDM)

Southern California Bio (SoCal Bio)

University Enterprise Laboratories (UEL)

Medical Device Manufacturers 

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Brochures

Clinical Services

Clinical Strategy

RCRI Overview

Regulatory Quality Services

Reimbursement Services


Case Studies

Avoiding market access delay due to incorrect product classification

Lessons learned from missing the mark with FDA hot buttons

Overcoming remediation challenges while keeping operations running

Innovation can be viewed as the application of better solutions that meet existing market needs