The FDA Group's Consultant Finder

023

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 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