Medical Device and In-Vitro
Diagnostics Development
AVS provides lifecycle support in quality, regulatory, commissioning, qualification, and validation
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
The client is a leading San Francisco based biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases such as targeted antibodies for cancer.
AVS assisted our client in upgrading their manufacturing space from a Biosafety Level 1 GMP facility to a Level 2 GMP facility. We were able to complete the entire project on schedule and within budget. Moreover, our documentation efforts to demonstrate full traceability was deemed appropriate by our client’s quality assurance team.
We were able to support our client throughout this entire transition process, from gap analysis to final equipment installation. Because of our efforts, this pharmaceutical manufacturer was able to manufacture medication with the lentivirus vector material. This collaboration allowed our client to focus on what they do best – develop medicines to help improve their target patient’s quality of life.
While re-visiting some protocol tests initially tested by the technician, we observed some anomalies in test results that were shown as “Passed”. Upon further investigation it was found that the technician did not detect that some barcode scanner cameras were installed upside down.
This was overlooked because the barcode scanner returned sets of values of 0's and 1's that can sometimes give identical results depending on the barcode being scanned. This was also overlooked because there were no sufficient tests to challenge the system.
A positive outcome was that important lessons learned were captured for the client. This led the QC laboratory team and Quality team to evaluate their business process to identify the gaps that allowed for unreliable test results.
This experience also helped the team have open discussions regarding team workload, and responsibilities they have to each other, to the company and ultimately to the patients.