Charles Parnham
Establish, certify, and operate 13485 & QMSR Quality Management Systems
- Role
- Principal at Parnham, Inc
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Charles Parnham
Established, certified, & operated Quality Management Systems (ISO 13485, ISO 9001, ISO 15189).especially with CLIA (LDT) coordination• Achieved FDA approval, FDA clearance, CE Certification, CMDCAS approval• Director of Operations | Director of Quality• Installed, retrofitted, and relocated manufacturing lines & clean facilities• Generated Risk Management Files, Design History Files, Usability Files • Generated and executed Design Validation Plans and Master Validation Plans• Assembled Design Dossiers, Technical Files, 60601 filing; contributed to FDA filings.STANDARDS & REGULATIONS PRACTICED.21 CFR 820 Quality System Regulation.IVDR (Regulation (EU) 2017/746).ISO 13485:2016 Med dev — QMS — Requirements for regulatory purposes.ISO 9001:2015 Quality management systems – Requirements.ISO 14971:2019 Application of risk management to medical devices.IEC 60601 Medical electrical equipment.IEC 61010 Safety req. for electrical equipment for measurement, control, & lab use.IEC 62304:2015 Software life-cycle process.IEC 62366:2015 Application of usability engineering to medical devices.ISO 10993 series Biological evaluation of medical devices.ISO series Sterilization of health care products.ISO 14644 series Cleanrooms and associated controlled environments
Experience
Principal
Apr 2013 — Present · San Mateo, CA, US
Quality Management Systems, Project Engineering, Design Assurance, and Quality Assurance • SaMD• Gene therapy, T-cell therapy• Esophageal temperature management• Coronary sinus stent• Companion Diagnostics (CDx)• CLIA executed In Vitro Diagnostic (IVD)• Smart phone IVD (SaMD)• Cardiology drug • Cancer drugs• DNA medicines• DNA, RNA diagnostics• Protein-protein diagnostics• Nitinol devices and delivery systems• rH collagen corneal implant• Contract Manufacturing• Bone Graft Substitute, Orthopedic implants• Implantable drug pump• Sternal closure implant• Blood collection tube• Guidewire• Surgical heart valve / Percutaneous heart valve• Blood glucose / Blood coagulation monitoring • Abdominal aortic aneurism stent
Education
Virginia Tech
B.S., Chemical Engineering
University of Colorado Boulder
Ph.D., Biochemical Engineering
University of Colorado Boulder
M.S., Biochemical Engineering
Skills
- Design Control
- Start-Ups
- Design Development
- Design Validation
- Doe
- Process Validation
- Iso 14971
- Fmea
- Cgmp
- Qsr
- Iso 13485
- V&V
- Quality System
- Gmp
- Medical Devices
- Design Research
- Validation
- Pharmaceutical Industry
- Product Development
- Product Launch
- Quality Assurance
- Quality Management
- Design of Experiments
- Iso
- Capa
- Quality Control
- Manufacturing
- Root Cause Analysis
- R&D
- Commercialization
- Testing
- Regulatory Submissions
- Biomedical Engineering
- Process Simulation
- Biotechnology
- Software Documentation
- Clinical Trials
- Minitab
- Lifesciences
- Technology Transfer
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