Medical Device and In-Vitro
Diagnostics Development
AVS provides lifecycle support in quality, regulatory, commissioning, qualification, and validaton
Concept
Development
Plan
Design/Build
Comissioning,
Qualification &
Validation (CQV)
Design/Transfer
Commercial
Production
Services
Medical Devices / In Vitro Diagnostic Services
- Agency Submissions: IDE, HCE, Master Files, etc.
- Batch Review and Disposition
- CE Mark/MDD/IVDD Risk AssessmentCFR Parts 11, 50, 56, 801, 803, 807, 812, 820
- Develop and execute validation protocols and prepared the reports
- Develop and implement preventative maintenance program
- Develop Risk Management Plan, and conduct Hazard Analysis, FMECA, and FTA
- EC 60601, 60812, 31010, 62304 EU MDR/IVDR Regulatory Strategy & Compliance
- Establish quality systems for device manufacturing
- FDA Meeting Preparation & Engagement
- FDA-483 &/or Warning Letter Response & Remediation
- Health Authority Response & Remediation Audits, Assessments & Gap Analyses
- Implement corrective actions (CAPA) based upon FDA warning letter citations
- Information Technology: CSV, SDLC, Part 11 Compliance
- Inspection Support & Facilitation Mock GXP Regulatory Inspections
- Internal audit support per QSRs, identification of system deficiencies and assistance with corrective actions
- ISO 9001, ISO 13485, ISO 14155, ISO 14971 21 Certifications
- Lab, clinical, and scientific operations support
- Lab instrument, software systems/network validation
- Pre-Approval Inspection (PAI) Readiness Preparation & Planning
- Prepare and implement QSR training program for combination products
- Product Development 510(k)/PMA Submissions
- Provide regulatory support for 510k filing
- QSR Auditing: In-Vitro Diagnostic, Medical Device, ISO 13485, MDSAP/Qualification/For Cause, etc.
- Quality Management Systems
- Sponsor/CRO/CMO Training & Readiness
- Strategy development for handling combination product FDA requirements late in the development cycle, and wrote compliance documentation
QC
Lab Study
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