With more than 45 years of combined industry experience, Your RAQA provides regulatory compliance services for Medical Device, IVD and LDT to IVD conversion that delivers maximum value to your business with minimal disruption 
- Multi-site, USA (East & West Coasts) & India (Pune & Chennai).

List of services:
- US FDA representative for Outside US clients & FDA communication management
- Establishment registration and device listing
- Pre-Submissions
- 510(k), Denovo classification, IDE and PMA preparation, advice, review, submission, followup, post market changes and remediation
- Medical device classification
- Medical device exempt device identification
- ISO 13485/QSR/QMSR Quality Management System Preparation, advice, review, training and remediation
- ISO 13485 audits
- MDSAP audit support with a current 3rd party MDSAP auditor on staff 
- Consulting, planning and testing - General Safety IEC 60601-1, EMI/EMC IEC 60601-1-2 and related corollary standards, Biocompatibility/Biological evaluation and toxicology - ISO 10993 series
- Clinical evaluation, testing and clinical trials - Consulting, planning and execution of clinical evaluation and trials to meet US FDA requirements
- CE marking audits - MDR and IVDR including Technical file preparation, advice, review, submission and followup
- Health Canada licensing - IVD and non-IVD/Medical Device classification, preparation, advice, review, submission and followup
- Brazil, Japan, Australia licensing, registration and submissions

Services for CLIA labs to meet LDT regulation:
- Gap analysis of CLIA lab to LDT regulation
- Compliance with LDT regulation according to FDA timelines
- Assay classification to determine FDA submission route
- Pre-Submission
- 510(k), Denovo classification and PMA submissions
- IDE submissions and management of clinical evaluations
- Establishment registration and listing
- Training of CLIA lab personnel to FDA regulations and LDT regulation and corresponding procedures

Your RAQA

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