Quality Systems and medical device manufacturing compliance consulting, auditing, Quality Systems development, CAPA, Complaint Handling, MDR Reporting and Management, Management Review, Systems Optimization, training (internal and external) and training development, technical writing, claims development and auditing, Supplier / Contractor Management. We work with clients in the medical device and diagnostic industries to develop quality assurance and regulatory strategies for compliance with global regulatory requirements and standards.Regulatory Strategies and Quality PlanningQuality Systems AuditingGlobal Quality Systems Implementation and RemediationFDA / Notified Body Inspections and AuditsRegulatory Compliance TrainingElectronic Quality Management Systems Implementation / ValidationDesign and Development Software as a Medical Device (SaMD)Human Factors Engineering / UsabilityRisk ManagementMarketing Authorizations: 510(K), MDL, CE MarkClinical Evaluation ReportsPost-Market SurveillanceOutsourced Quality Management

Christopher Ford is a senior level Quality and Regulatory professional with more than twenty-five years of experience in Quality System development, implementation and compliance, CAPA Remediation, Design and Development and Manufacturing of diagnostic, point of care and therapeutic medical devices, including software-controlled devices and Software as a Medical Device. Christopher provides both strategic and tactical solutions to assist organizations in meeting global compliance objectives cost-effectively.ISO, QSR, MDD / EU MDR, and CMDR audit/complianceMedical Device Single Audit Program (MDSAP)Quality System development/implementationSoftware Development Life Cycle IEC 62304Product development and commercializationCAPA Remediation / Root Cause InvestigationsFDA Product Submission 510(k)Equipment, process, and software validationRisk Management ISO 14971Design verification/validation planning and testingUsability Engineering and Human Factors IEC 62366EBG Advisors, Inc., based in Washington, D.C., is a national consultancy that offers a multi-disciplinary approach to helping health care and life sciences companies advance their interests in the regulatory, policy and market spheres. EBG Advisors’ network of top-tier professionals deliver tailored solutions spanning the domains of strategy, policy analysis, clinical and business operations, and finance.Epstein Becker & Green, P.C. (“Epstein Becker Green”) is a law firm with more than 100 health care and life sciences attorneys. By partnering with Epstein Becker Green’s attorneys, EBG Advisors is able to capitalize on the law firm’s over 40 years of experience in the health care industry and make sure that all the legal aspects of a project are properly addressed.

WHAT WE DONicopliance, Inc. is dedicated to facilitating Premarket Tobacco Applications with the US Food and Drug Administration and European tobacco product notifications with the European Commission. We are a unique team of experts with more than 25 years experience in Regulatory Science, compliance and quality assurance, developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of ENDS products. We provide complete toxicological risk assessment, product analysis and analytical testing, stability / leachable testing, environmental assessment, and quality management system support.OUR PHILOSOPHYWe are dedicated to the development and application of scientific methods, tools, approaches, and other relevant processes derived from various scientific disciplines used to support regulatory and other policy objectives in the ENDS industry. The predominant focus of Regulatory Science pertains to human health and well-being. Nicopliance was created to disrupt the regulatory compliance services industry and allow businesses of all sizes to survive and thrive under e-cigarette regulations. Our aim is to reduce operating costs and eliminate human error potential for our customers.We are currently not accepting new engagements.

Provided food and beverage content, advertising, marketing (traditional and social media) and public relations services to restaurants, food and beverage distributors, and mobile food vendors globally. Content included food reviews, recipes, business advice, industry news, and event coverage.Reviewed over 200 food truck menus for Food Network and more than 200 restaurants globally, amassing a fan base of nearly one million people, which I continue to maintain.Organized annual fundraisers, supporting Toys 4 Tots, Salvation Army, local food banks, and homeless shelters in San Francisco, CA, Sacramento, CA, Nevada City, CA, and Alameda, CA, raising $500,000 between 2011 and 2015.Noteworthy:2011 - Marketing and Public Relations, World's Largest Hamburger, Guinness Book of World Records, Ovations, LLC. (multi-media campaigns, press / news coverage, social media, viral marketing), raised $5,000 for food banks locally.2012 - Marketing and Public Relations, World's Largest Margarita - The Calarita, Guinness Book of World Records, Ovations, LLC. (multi-media campaigns, press / news coverage, social media, viral marketing), yielding 134,000 margaritas which were sold for $10 each for a total of $1,340,000.00 to support local food banks.Media / Publication - Food critic, journalist, bloggerDigital and Traditional Advertising CampaignsTraditional and Social Public RelationsFully Integrated Social Media Marketing

Food Critic and Food Writer on Eat Street, a Paperny Entertainment production for five seasons. The show featured food trucks throughout North America during the burgeoning food truck revolution. I specialized in gourmet culinary presentations. I was tasked with supplying printed and web publications with original written copy that was used as part of features on food, drink and restaurant reviews. I reviewed over 200 menus, critiquing more than 500 dishes, before moving into the restaurant space. I appeared on multiple episodes during Season 4, and produced a web TV series on Food Network's Eat Street website. I also hosted the Food Network, Eat Street Food and Wine Festival, Trucks on the Vine during Season 4 in Alameda, CA for more than 10,000 attendees.I attended new restaurant launches, special themed nights and trade shows. My reviews were syndicated to major outlets and I provided reviews of property or entertainment venues from time to time.

Commercial Visual Communications (www.fotomojocf.com)Photography, strategic branding, campaign development, copy development, advertisement design and layout

Work with clients in the medical device, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA regulations and applicable international requirements. Conduct assessments of client sites, procedures, and programs to determine compliance. Quickly identifies gaps and weaknesses, and develops strategies to assist the client in developing cost-effective and efficient solutions.Conduct and report quality systems audits, specializing in FDA Class II and III medical device manufacturers.

Quality Systems and medical device manufacturing compliance consulting, auditing, Quality Systems development, CAPA, Complaint Handling, MDR Reporting and Management, Management Review, Systems Optimization, training (internal and external) and training development, technical writing, claims development and auditing, Supplier / Contractor Management.

Non-profit, fundraising for California agriculture. Hosted and produced the Foods4Thought Food and Wine Festival in Grass Valley for 18,000 guests, raising $250,000 for local high school agricultural and 4H programs.

US FDA Class II Medical Device Manufacturer (physical medicine devices)Management representative, and Regulatory point of contact for the company responsible for oversight of the quality management system with specific emphasis on the internal audit system, CAPA, Complaint Handling, and the supplier audit system.Established and implemented an ISO 13485:2003 / QSR / CMDCAS / MDD compliant quality management system within 90 days, and developed and delivered associated training materials.Established and implemented a Home Medical Device Retailer program, and attained licensing allowing the organization to dispense medical devices to patients. Managed a 510(K) application project for submission to FDA.Successfully hosted one State (CA Department of Health) and one Federal (US FDA) inspection, minimizing inspectional observations (483) and reducing the company’s liability, and developed timely responses and negotiated with FDA to successfully close inspection reports.Developed user manuals for CE mark and technical files for submission. Managed certified translation services for all Game Ready brand user communications.

US FDA Class III Medical Device Manufacturer (glucometer and insulin delivery system devices) Developed, implemented and maintained the divisional audit program, including internal quality system compliance, clinical practices, and supplier/contract manufacturer quality Audited PMA applications prior to submission.Lead and directed staff, and conducted first and second-party audits, including quality system, clinical trials, clinical investigational sites, suppliers, and contract manufacturers for compliance with applicable corporate and divisional policies and regulatory / statutory requirements.

US FDA Class III Medical Device Manufacturer (medical image (CAD) analyzer devices)Management representative, and point of contact for the company responsible for oversight of the quality management system. Directly managed Document Control, Management Review, CAPA, Complaint Handling/Investigation, Inspection, Internal and Supplier Audit, Training (internal and external) Nonconforming Material, and Equipment Controls.Established and implemented an ISO 13485:2003 / QSR / CMDCAS / MDD / r-PAL compliant quality management system, and developed and delivered associated training materials. Achieved certification and subsequent recertification with minimal nonconformities noted.Successfully hosted multiple State (CA Department of Health) and Federal (US FDA) inspections, minimizing inspectional observations (483) and reducing the company’s liability, and developed timely responses and negotiated with FDA to successfully close inspection reports.Developed and executed validation test protocols to implement the Agile PDM electronic document management system.Lead continuous improvement efforts, and participated on cross-functional committees focused on improving performance, cost and speed relative to customer satisfaction.

US FDA Class II Medical Device Manufacturer (evoked response auditory stimulator devices carboxhymoglobin assay diagnostics )Management representative, and point of contact for the company responsible for oversight of the quality management system. Directly managed Management Review, CAPA, Complaint Handling/Investigation, Inspection, Internal and Supplier Audit, Training (internal and external) Nonconforming Material, and Equipment Controls.Established and implemented an ISO 13485:2003 / QSR / CMDCAS / MDD / r-PAL compliant quality management system, and developed and delivered associated training materials. Achieved certification and subsequent recertification with minimal nonconformities noted.Successfully hosted multiple State (CA Department of Health) inspections, minimizing inspectional observations and reducing the company’s liability, and developed timely responses to successfully close inspection reports.Lead continuous improvement efforts, and participated on cross-functional committees focused on improving performance, cost and speed relative to customer satisfaction.Managed, lead and / or conducted approximately 65 supplier audits (ISO 13485/9001/MDD/QSR) internationally.

US FDA Class III Medical Device Manufacturer (obstetrics/gynecology catheters)Established procedures and managed systems for Document Control, CAPA, Incoming and final Inspection, Internal and Supplier Audit, Nonconforming Material, and Equipment Controls/Calibration.

Established / Implemented a QSR / ISO 13485 documentation system.Developed and managed the company's document control system.

Coordinated purchase order deliveries to manufacturing assembly lines to assure JIT delivery and no work stoppages.

Established project management system, forecasting, inventory control, job costing and planning and assisted in LAN/WAN development.

Special Duty Assignment