KNOWLEDGE BASE
- 21 CFR Part 820 The Quality System Regulation
- 21 CFR Part 4 Current Good Manufacturing Practice Requirements for Combination Products.
- 21 CFR Part 11 Electronic Records; Electronic Signatures
- 21 CFR Parts 50, 54, 56, 812 and 814, Good Clinical Practices Government Code
- 21 CFR Part 803 Medical Device Reporting
- 21 CFR Part 806 Medical Devices: Reports of Corrections and Removals
- 78 FR 58785 Unique Device Identification System, Final Rule
- Docket No. FDA-2014-N-0189 Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act
- ISO 9001 Quality management systems — Requirements
- ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
- IEC 62366 Medical devices — Application of usability engineering to medical devices
- European Parliament Directive 93/42/EEC, The Medical Device Directive
- European Parliament Directive 98/79/EC, The In-vitro Device Directive
- European Parliament Directive 2014/40/EU Tobacco Products Directive
- CMDR (Canada), SOR/98-282, P.C. 1998-783 May 7, 1998 and amendments
- Japanese r-PAL GMP, Ordinance No. 169
- Brazilian Health Surveillance Agency (ANVISA) Resolution RDC no. 2
- Division 104, Part 5, State of California, Sherman Food, Drug and Cosmetics Law, including those parts relative to Home Medical Device Retailer
- ISO 14971:2007 Medical devices — Application of risk management to medical devices
- ISO/IEC 16085 Systems and software engineering — Life cycle processes — Risk management
- IEC 60601-1 ed 2, 3 and 4 Medical electrical equipment - General requirements for basic safety and essential performance
- ISO/IEC 12207 Systems and software engineering — Software life cycle processes
- IEC 62304 Medical device software — Software life cycle processes
- ISO/IEC 27034-1 Information technology — Security techniques — Application security
- Federal Information Security Management Act (P.L. 107-347)
- NIST SP 800-53 rev3 Recommended Security Controls for Federal Information Systems and Organizations
DEVICE EXPERIENCE
Experience with pulmonary inhalation, intravenous, subcutaneous, and implantable delivery devices (combination products), surgical laser systems, mobile health (mHealth) devices, ultrasonic pulsed echo imaging systems, catheter guide wires, diagnostic intravascular catheters, powered laser surgical instruments, obstetrics/gynecology surgical instruments, clinical chemistry, physical medicine devices, radiology, neurology, immunology, pathology and hematology, including a tubal occlusion inserts (permanent contraception), point of care blood chemistry analyzers and colorimetric reagent test panels, glucometers and insulin delivery systems (BGM / CGM / Pumps), carboxhymoglobin assays, power inflatable tube massagers, medical image (CAD) analyzers, nuclear uptake probes, radionuclide brachytherapy source, evoked response auditory stimulators, automated cell-locating devices, automated image analysis microscopes, emission computed tomography system, differential cell counters, Software as a Service (SaaS) in medical devices, spectacle lenses, therapeutic flotation mattresses.
Regulatory Expertise:
Medical Devices – Durable, Electronics, Implants, Software, Software as a Service (SaaS), Sterile, Delivery Devices and Systems, Combination Products
Adverse Event (SAE) Evaluation, ASQ Certified Auditor, Audits – Certification/State Licensing/Due Diligence/GCP/GMP (Biologic)/ISO/ Mock/ Pre-Approval Inspection/ Quality System Inspection Technique (QSIT)/Quality System Regulation (QSR)/Supplier, Clinical – Labeling, Electronic Records & Electronic Signatures; 21 CFR Part 11 EPA, FDA - 483 and Warning Letter Responses, Hazard Analysis, ISO - 13485/ 9001/9002/ 9003/14971 (Risk Management) / In-vitro Diagnostic Directive (IVDD)/ Medical Device Directive (MDD), ISO certified auditor, ISO lead auditor, Quality Assurance, Quality Control, Quality Management, Quality Systems Development and Implementation, Regulatory Affairs
Submissions – Pre-Submissions, 510(k), PMA
Technical Expertise:
Batch Record Review, Calibration, CE Technical File Assessment, Computer Validation, Corrective and Preventive Action (CAPA), Design Controls, Development History Report Writing, Document and Records Controls, Engineering - Software/Controls/Design/ Manufacturing/Process/Project, Environmental Monitoring, Equipment Validation, ERP, Facility Validation, Gap Analyses, Lean Manufacturing, Medical Devices, Metrology/Calibration, Non-conformance Investigations, Out-of-Specification (OOS) Investigations, Packaging and Labeling, Pre-Approval Preparation and Inspection, Process Optimization, Process Validation, Program Management, Project Management, Quality Engineering, Risk Analysis – FMEA/FMECA/FTA/HAACP/, Root Cause Analysis, Software - Development Quality Programs, SOP Development and Implementation, Software/Hardware Validation, Supply Chain and Supplier Management, Technical Writing, Training-GMP, QSR, ISO, Validation Protocol and Report Writing
WORK EXPERIENCE:
2006 – Present Ford & Associates
Christopher Ford Enterprises, Inc., Oxnard, CA
Senior Partner, Medical Devices Consultant
EMPLOYMENT HISTORY:
2006 – 2007 Game Ready, Berkeley, CA
Manager, Quality Systems and Regulatory Affairs
- Management Representative
- ISO 13485:2003 / QSR / CMDCAS / MDD QMS Development and Training
- Risk Management – ISO 14971
- Home Medical Device Retailer License
- 510(K) Submission
2004 – 2005 Abbott Laboratories, Abbott Diabetes Care, Alameda, CA
Manager, QARA Audit
- Established Division Audit Program
- Managed Audit Staff, Training, Continued Development
- Internal Audit
- Supplier Audit
- Clinical Audit
- PMA Submissions Audit
2001 – 2003 R2 Technology, Inc. (Hologic), Sunnyvale, CA
Manager, Quality and Continuous Process Improvement
- Management Representative
- Directly managed Management Review, CAPA, Complaint Handling/Investigation, Risk Management Program, Inspection, Internal and Supplier Audit, Training (internal and external) Nonconforming Material, and Equipment Controls.
- Continuous Improvement Project Management
- ISO 13485:2003 / QSR / CMDCAS / MDD QMS Development and Training
- ERP Implementation / Validation
2000 –2001 Natus Medical, Inc., San Carlos, CA
Lead Quality Engineer / QA Manager
- Management Representative
- Directly managed Management Review, CAPA, Complaint Handling/Investigation, Inspection, Internal and Supplier Audit, Training (internal and external) Nonconforming Material, and Equipment Controls.
- Product Performance Monitoring and Reporting supporting company Risk Management initiatives
- ISO 13485:2003 / QSR / CMDCAS / MDD QMS Development and Training
- Managed, lead and / or conducted approximately 65 supplier audits (ISO 13485/9001/MDD/QSR) internationally.
1991 - 2000 Positions Include:
- Materials / Procurement –
Materials Handler, Receiving Clerk, Expeditor / Planner, Buyer, Sr. Buyer, Purchasing Manager
- Quality Systems Management –
Document Control Specialist, Technical Writer / Reviewer - Policies, Procedures, Process Maps, User Manuals, FAQ’s, Web Content, Quick Guides, Brochures, Direct Mail pieces, Trade Show booth panels, and other collateral / QA Specialist, Quality Engineer, Sr. Quality Engineer, QA Supervisor, QA Manager
CERTIFICATIONS
1998 – Certified Quality Auditor (CQA), American Society for Quality (ASQ)
2004 – Certified Quality Auditor (CQA), American Society for Quality (ASQ), # 32383
2005 – ISO 13485:2003 Lead Auditor (QMS-LA), RABQSA, AQS Management Systems, Inc., # Q8351
TRAINING
2015 – ISO 13485 3rd Edition, BSI
2015 - RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971, Gantus
2015 – ISO 9001:2015 Implementation Changes, BSI
2015 - Understanding Changes to EN-60601 and How to Maintain MDD Compliance, BSI 2014 – ISO 9001:2015 Overview, UL DQS
2014 – Update on ISO 13485:201X – 3rd revision, BSI
2014 – DIS 9001:2014, Understanding the Draft International Standard, IRCA / Chartered Quality Institute
2014 – Tips to a Successful Remediation, ALKU Quality 2014 – CE Marking, Intertek
2013 - IEC 60601-1-11 Training for Makers of Home Healthcare Devices, MDDI Online 2013 – Interoperability & Mobile Health, eHealth-Medical Systems
2013 – FDA’s Unique Device Identification (UDI System): The Final Regulation, FDA 2012 – Designing for Compliance to IEC 60601-1 3rd Edition, UL
2012 – Documenting Required ISO 14971 Elements in the 60601-1 TRF, UL 2012 – CMDCAS for Medical Device Manufacturers, BSI
PUBLICATIONS
Journal of Diabetes Science and Technology, Volume 7, Issue 6, November 2013; Diabetes Professionals Must Seize the Opportunity in Mobile Health; Brian Brandell, Ph.D., and Christopher Ford, B.A.
PROFESSIONAL AFFILIATIONS
American Society for Quality (ASQ), Los Angeles Section – Biomedical Division; Food, Drug and Cosmetic Division
Regulatory Affairs Professionals Society (RAPS)
EDUCATION
|
2003 |
Business Management / Marketing, University of Phoenix, San Francisco, CA |
|
2001 |
Strategic Planning, California State University, Dominguez Hills, CA |
|
1998 |
Journalism / Mass Communications, San Jose State University, San Jose, CA |
PROJECT EXPERIENCE
|
Project Type |
Device |
Highlights |
|
2017 |
||
|
QMS Upgrade / Management |
Class II Orthopedic bone fixation devices |
Upgrade to ISO 13485:2016 Added ANVISA requirements |
|
QMS Audit |
Class II Orthopedic bone fixation devices |
QSR, ISO 13485:2003, CMDR, MDD |
|
510(k) Submission – Technical Review |
Class II Motorized Wheelchair |
Technical review of documentation with a focus on device software. |
|
QMS Audit |
Class II Physiological, Patient Monitor |
QSR, ISO 13485:2003, CMDR, MDD, JPAL, ANVISA |
|
Quality Management |
Class I Therapeutic Flotation Mattress and Nasal Aspirator |
Management Representative Director of Quality and Regulatory Affairs Restructured QMS and updated Technical Files |
|
Project Type |
Device |
Highlights |
|
2016 |
||
|
Quality Management |
Class I Therapeutic Flotation Mattress and Nasal Aspirator |
Management Representative Director of Quality and Regulatory Affairs Restructured QMS and updated Technical Files |
|
COO, 483 Response, Remediation |
Class II Electrosurgical, endoscopic unit |
Acting Chief Operating Officer CAPA remediation FDA 483 Response Recall Management Destruction Order |
|
QMS Implementation |
e-Liquid, nicotine delivery |
ISO 9001:2015 QMS implementation for e- liquids manufacturer. |
|
Regulatory Submissions Processes |
e-Liquid, nicotine delivery |
Developed regulatory processes for submission of European tobacco product notifications and US FDA premarket tobacco application for multiple clients. |
|
Project Type |
Device |
Highlights |
|
QMS Audits |
Class II Image-intensified fluoroscopic x-ray system Class II Stationary X-Ray System and Anti-Scatter Grids |
QSR, ISO 13485:2003, CMDR, MDD, JPAL, ANVISA |
|
Project Type |
Device |
Highlights |
|
2015 |
||
|
Mock QSIT Inspection and CAPA Remediation |
Class II Monitor, Physiological, Patient (with arrhythmia detection or alarms) |
CAPA remediation, Mock QSIT Inspection |
|
483 Response, Remediation, Close Out Audit |
Class II Ophthalmic laser |
Close out certification audit for CAPA remediation, and 510(k) submission response. |
|
QMS Audits |
Class II Multipurpose interventional system |
QSR, ISO 13485:2003, CMDR, MDD, JPAL, ANVISA |
|
QMS Implementation |
e-Liquid, nicotine delivery |
ISO 9001:2015 QMS implementation for e- liquids manufacturer. |
|
QMS Audits |
Class II Image-intensified fluoroscopic x-ray system Class II Stationary X-Ray System and Anti-Scatter Grids |
QSR, ISO 13485:2003, CMDR, MDD, JPAL, ANVISA |
|
Technical File |
Class II Monitor, Physiological, Patient (without arrhythmia detection or alarms) |
Compiled technical file for CE Mark submission |
|
Mock QSIT Inspection |
Class I PUMP, BREAST, NON- POWERED Class I SHIELD, NIPPLE Class II PUMP, BREAST, POWERED Class I PUMP, BREAST, NON- POWERED Class II PUMP, BREAST, POWERED Class I PACK, HOT OR COLD, REUSEABLE Class II LIGHT BASED OVER-THE- COUNTER HAIR REMOVAL Class I SHIELD, HFS |
Mock QSIT Inspection in preparation of a scheduled FDA inspection. |
|
Project Type |
Device |
Highlights |
|
Due Diligence Assessment |
Lidocaine Transdermal Patch and container closure |
QMS software implementation, Process Validation, Supplier Selection and Audit, and 510(k) submission |
|
QMS Audit – Pre-Stage I Certification |
Class III, Pulmonary Drug Delivery System (PDDS) Device |
Combination product. PEGylation and polymer conjugate technology |
|
QMS Audit |
Class II Monitor, Physiological, Patient (without arrhythmia detection or alarms) Class II Transmitters and Receivers, Physiological Signal, Radiofrequency Class II System, Measurement, Blood-Pressure, Non-Invasive Class I Scale, Stand-On, Patient |
QSR, ISO 13485:2003, CMDR, MDD |
2014 |
||
|
QMS Implementation / 510(k) Submission |
Class II, Electrocardiograph, Ambulatory (Without Analysis) Medical Magnetic Tape Recorder |
QMS development, QMS software implementation, Technical File Audit, Process Validation, Supplier Selection and Audit, and 510(k) submission |
|
QMS Audit |
Class II Monitor, Physiological, Patient (without arrhythmia detection or alarms) Class II Transmitters and Receivers, Physiological Signal, Radiofrequency Class II System, Measurement, Blood-Pressure, Non-Invasive Class I Scale, Stand-On, Patient |
QSR, ISO 13485:2003, CMDR, MDD |
|
510(k) Submission – Technical Review |
Class II Motorized Wheelchair |
Technical review of documentation with a focus on device software. |
|
QMS Audit |
Class II Physiological, Patient Monitor |
QSR, ISO 13485:2003, CMDR, MDD, JPAL, ANVISA |
|
Webinar – Private Client |
Drug-device Combination Product |
Designed a 2-hour webinar specific to client business model. Combination Product Device Development and Manufacturing; Part 1: Design Control Design control regulation 21 CFR 820.30 and how it applies to Combination Products |
|
Warning Letter Remediation |
Class II non-sterile Computed Tomography and Nuclear Medicine Imaging Systems |
Assisted in the assessment of ongoing remediation activities to correct FDA-noted deficiencies |
|
Project Type |
Device |
Highlights |
|
Software / Applications / IT cGMP Audit |
Global Multi-site, Multi-Device (Class II) |
21 CFR Part 820.70(i) 21 CFR Part 11 AAMI TIR36:2007 ISO/IEC 27034-1:2011-11 (E) ISO/IEC 27000:2014 |
|
MDEL Inspection Prep |
Class I Spectacle Lenses |
QMS gap analysis, documentation review, and procedure revisions for Canadian MDR (SOR/98-282) compliance. |
|
Claims Analysis |
Class II Germicidal Ultraviolet Disinfection Device |
Competitive claims analysis of six currently marketed devices for design input considerations. |
|
QMS Audits |
Class II Image-intensified fluoroscopic x-ray system Class II Automatic resp. Manual Radiographic Collimator Class II Physiological, Patient Monitor Class II Stationary X-Ray System and Anti-Scatter Grids |
Quality Management Systems audits at five separate business units operating under different quality management systems over the course of five months. QSR, ISO 13485:2003, CMDR, MDD, JPAL, ANVISA |
|
QMS Audit |
Class II non-invasive and removable prosthetic bone conduction hearing devices |
ISO 13485:2003 FDA 21 CFR Part 820 ISO 14971:2012, European MDD (93/42/EEC as amended by 2007/47/EC) Canadian MDR (SOR/98-282) |
|
Design Controls Implementation (Combination Product) |
Class II Auto-Injector |
Development of custom design controls policy document for a global virtual manufacturer |
|
QMS Audits (Multiple Suppliers) |
Class II blood-, urine-, and saliva collection systems, products for general laboratory use and accessories for industrial, medical and research use. |
QSR/ISO 13485:2003/MDD Second Party Audit (supplier audit) and technical documentation review |
|
QMS Development / Regulatory Strategy Development |
Class II Germicidal Ultraviolet Disinfection Device |
QMS Implementation, EPA / FDA reporting program, 510(k) strategy, DHF development |
|
Supplier Compliance Audit |
Class II Clinical Chemistry, Blood specimen collection device with additive |
ISO 13485:2003 Second Party Audit (supplier audit) and technical documentation review |
|
Warning Letter Response |
Class I Spectacle Lenses |
FDA Warning Letter response and QSR audit and report, Implementation of medical device reporting, product recall, CAPA and internal quality audit procedures, and MDR / CAPA training |
|
Project Type |
Device |
Highlights |
|
2013 |
||
|
QMS Development |
Class I Therapeutic Flotation Mattress and Wheelchair Accessories |
QMS implementation and training in 21 CFR 820 and ISO 13485:2003 / Regulatory Affairs adviser |
|
Regulatory Impact Assessment |
Environmental Control Equipment Manufacturer for Healthcare Institutions |
Regulatory and technical assessment, and report |
|
QMS Audit |
Class II Surgical Laser Systems |
13485:2003 Quality Systems Audit |
|
QMS Audit |
Class II Intravascular Ultrasound Devices |
ISO 13485:2003 / QSR internal quality audit and report |
|
Due Diligence Technical and Compliance Audit |
Class II Blood Glucose Monitoring Device / Class III Continuous Glucose Monitoring System |
DHF Technical Review, Quality System Assessment, Clinical Data Review and due diligence report for business acquisition |
|
Postmarket Performance Data Analysis – Combination Product |
Class III Needleless Subcutaneous Drug Delivery System |
Postmarket performance data analysis and presentation |
|
QMS Audit – Combination Product |
Class II Skin and Wound Cleanser |
ISO 13485:2003 Certification Readiness Audit and Report |
|
QMS Audit |
Class II Balloon Sinuplasty devices |
ISO 13485, 21 CFR 820, SOR 98-282, 93-42- EEC Internal Quality System Audits and Reports |
2012 |
||
|
510(k) Submission |
Class II Cardiovascular therapeutic device |
510(k) for a hypothermia device, technical documentation review for DHF and Technical File |
|
QMS Development |
Class III Software as a Service (SaaS) device, glucose monitoring, CGM, insulin pump |
QMS implementation and training in 21 CFR 820, ISO 13485, SOR 98/282 CMDR, MDD 93/42/EEC, and FISMA P.L. 107-347 / NIST SP 800-53 |
|
QMS Audit |
Class II High power diode laser components and systems |
QSR / 13485:2003 Quality Audit with gap analysis |
|
QMS Audit – Combination Product |
Class III Implantable ocular drug delivery device |
Pre-Clinical Quality Management System audit with report, and DHF development |
|
QMS Audit |
Class II Pelvic Health Devices |
Multiple ISO 13485:2003 Second Party Audits (supplier audit) and reports |
|
Pre-IDE Submission Consultant – Combination Product |
Class II Antimicrobial Drape / Combination Products |
Implementation of design controls system for combination products, including products with software, DHF, and draft Pre- IDE submission for a new antimicrobial drape. |
|
QMS and DHF Development – Combination Product |
Class II Sodium Chloride Inhalation Solution |
Quality System development and implementation for a combination drug / device, and development of the DHF |
|
2011 |
||
|
QMS Audit |
Class III implantable spinal cord stimulation system |
QSR Audit and report |
|
Due Diligence Assessment |
Class II Cardiovascular therapeutic device |
Technology Review, DHF Audit, 510(k) Audit, Due Diligence Technology Acquisition Assessment |
|
QMS Development |
Label Manufacturer |
Development of an ISO 13485:2003 compliant quality management system for resale |
|
Technical Transfer Support – Combination Product |
Class III Implantable ocular drug delivery device |
Technical Transfer assessment and report, Pre-Clinical technical review, LHR Review, PFMEA Development Support, Process Validation Support, QSR Audit and report |
|
ERP Implementation Support |
Class II Intravascular Ultrasound Devices / Cardiology Imaging Catheters |
Internal Audits, Root Cause Investigation, Declaration of Conformity assessment, Product Certificate of Conformity Process Development, Nonconforming Materials System, Product Launch Support |
|
QMS Audit |
Class III Implantable Peripheral Nerve Stimulator with Software |
ISO 13485:2003 pre-certification audit with gap analysis and report |
2010 |
||
|
QMS Audit – Combination Product |
Class III Inhalation Delivery System |
ISO 13485:2003 Second Party Audit (supplier audit) and technical documentation review |
|
Technical Transfer Audit – Combination Product |
Class III Inhalation Delivery System |
Technology Review, DHF Audit, Supplier Controls |
|
QMS Development, PMA Support |
Class III CAD Imaging Software |
Quality Systems Development, Quality Audit, PMA preparation, Submission support, PAI Support, Process Validation |
|
QMS Audit |
Class III Nitinol stents and other devices |
Annex II / CMDCAS Upgrade preparation and audit |
|
Technical Transfer Audit |
Class III Inhalation Delivery System |
Review of DHF and IND documentation with report |
|
Quality and Regulatory Compliance |
Class II Hot/Cold Water Circulating Device with Software |
510(K) preparation and submission, Claims audit, 93/42/EEC Annex V audit, Competitor analysis |
|
QMS Audit |
Contract Manufacturing Organization of Class II medical devices and components |
ISO 13485:2003 Pre-Certification Audit to verify that modifications to the organization’s ISO9001:2000 quality management system conform to the requirements of ISO13485:2003 |
|
QMS Audit |
Class II Surgical Laser Systems |
13485:2003 Quality Systems Audit |
|
QMS Audit |
Class III Inhalation Delivery System |
ISO 13485:2003 Second Party Audit (supplier audit) and technical documentation review |