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Written by The FDA Group | Jul 11, 2022 8:23:57 PM

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 3^rdEdition, 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 3^rdEdition, 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

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