REGULATORY AFFAIRS & QUALITY ASSURANCE
REGULATORY AFFAIRS & QUALITY ASSURANCE
We offer a wealth of experience in development and management of FDA/ISO-compliant quality systems, regulatory filings and clinical study programs.
Regulatory Management
- FDA Product Classification Assessment
- Regulatory Plan
- Regulatory Submissions: 513(g), Q-Sub, 510(k), IDE, PMA, eCTD, CER, PMS/PMCF
- Marketing approvals from FDA, Notified Bodies (CE Mark), Health Canada, MHRA, MHLW, TGA,SAMR, KFDA, ANVISA
- Clinical Study Management
Quality Assurance
- Quality Management Systems (QMS)
- QMS Maintenance and refinements for efficiency
- ISO 13485, MDSAP Planning and Audit Support
- Risk Analysis & Risk Management Plan (ISO 14971, ISO/TR 24791)
- Biocompatibility Support (ISO 10993)
- Human Factors/Usability (HE75)
- Design Controls (product & Process validation/verification)
Clinical Research, Clinical Trials & Approvals
- Clinical Study Design, Protocol and Informed Consent Development
- IRB/Ethical Committee Approval
- Statistical Support for Study Group Sample Size
- Q-Sub & IDE Planning and Approval
- Study Site & Data Integrity Management (with CROs) through all study phases
- Statistical Analyses of Data
- Clinical Summary Report & Product Labeling
- 510(k), Original PMA, PMA-Supplement, eCTD for CE Mark
- Clinical Evaluation Report (Meddev 2.7/1 (4)
- Post-Market Surveillance (PMS) & Post-Market Clinical Follow-up (PMCF)