IRC Services

IRC offers our clients a full range of services. Click here for Regulatory Services, Quality Systems Services, U.S. Agent/Official Correspondent Services, and Training and Education Services.

Click here for the online form to contact IRC.

REGULATORY SERVICES
Strategic Planning from Design to Market Premarket Notification 510(k) Submissions New Products Product/Process Changes New Intended Use Premarket Approval Applications New Applications Supplemental Applications Investigational Device Exemptions FDA Applications "Abbreviated" Requirements Protocol Development Clinical Trial Management Study Initiation Monitoring Data Acquisition/Analysis FDA Reporting EU IVDMD Compliance CE Mark Technical Files Affiliate Authorized Representative	Mandatory Medical Device Reporting Complaint System Service Systems ComplaintMaster Control System Master File (DMF) Preparation and Submissions Labeling and Advertising Review Import/Export Approvals FDA Representation/Official Correspondent Compliance Crisis Management FDA Warning Letters Consent Decree Representation Recall Strategies and Management Litigation Support EU MDD Compliance CE Mark Technical Files Affiliate Authorized Representative
QUALITY SYSTEMS SERVICES
US Good Manufacturing Practices Audit and Inspection Systems Design and Analysis Corrective Action Plans SOP's, Documentation, and Implementation ISO/ EN Standards ISO 13485 ISO 9001/EN 46001 ISO 9002/EN 46002 Strategic Review and Planning Pre Assessment Certification Review Audit System Design and Documentation Notified Body Selection and Coordination	Verification and Validation Pre Production Technology Transfer Product Production Operations Facility and Environmental Controls DI and RO Water Systems Clean Room Operations Acquisition Audits and Evaluation Due Diligence Product Company/Manufacturing FDA Inspection Coordination Vendor Audits
U.S. AGENT/OFFICIAL CORRESPONDENT SERVICES
Medical Device Reporting Complaint Handling Management Coordination with US Importer/Distributor Annual Facility Registration & Device Listings QSR / GMP & Regulatory Systems Analysis/Auditing 510(k) Submissions	IDE Submissions Clinical Trial Management Premarket Approval Applications FDA Inspection Coordination Strategic and Regulatory Planning Personnel Training
TRAINING AND EDUCATION SERVICES
Regulatory Administration US Federal Food Drug and Cosmetic Act US Code of Federal Regulations International Requirements -- MDD93/42/EEC -- IVDMD 98/79/EC US Quality Systems Administration (cGMP) US Good Manufacturing Practices Quality Systems Regulations ISO/EN Standards Complaint Handling Systems Medical Device Reporting	Document Control Practices Submissions Premarket Notification 510(k) System Investigational Device Exemption and Clinical Trails Premarket Approval Applications Staff Development andEducation Senior and Executive Management General and Departmental Management Production and Quality Control Operations