KEVIN A. McLELLAN MEDICAL DEVICE REGULATORY EXPERTISE and

Memphis, TN ISO QUALITY SYSTEMS IMPLEMENTATION

email: ad1jxl@r.postjobfree.com

I provide consulting services to the healthcare industry. My areas of expertise include . . .

Commercialization of medical devices for U.S market

Medical device Quality systems implementation per FDA and ISO standards

HIPAA compliance for Providers and Business Associates

My efforts are organized under company name MedTech Results (since 2016). Clients have included established and early-stage medical device manufacturers, product designers, software developers, importers, repackagers, and test labs.

I’m certified as Lead Auditor for ISO13485 (Medical Device Quality Systems), through BSI. I’ve also done extensive work with ISO 14971 (Risk Mgmt), ISO 62304 (Med Device Software), and ISO 22301 Business Systems Continuity.

MEDTECH RESULTS (since 2016) Founder, Managing Consultant

Recent Projects & Clients

Risk Analysis & QMS development for AI-based medical software company (radiology). Also 510k Submission documentation. Imvaria.com (Palo Alto, CA)

Updated a legacy QMS to ISO 13485 standards for oral surgery device mfr. Achieved ISO 13485 Certification. Orthotractionpads.com, (Greenwich, CT.)

Major overhaul of QMS systems for mfr of Class I & II emergency care products used by first responders and DoD. Conducted internal Audit, Supplier Audits, Mgmt Review. H & H Medical Corp. (Richmond VA

Built an operational QMS system for a device manufacturer (post-surgery rehab devices, software). E2 Scientific (Los Angeles., CA)

Implemented QMS for a Class II opthamology product. Participated in ISO 13485 re-cert and surveillance audits. Device included software developed to ISO 62304 standards. iScreenVision (Memphis, TN)

Conducted Internal Audit and helped implement ISO 22301 standards for a radiology core lab.

Intrinsic Imaging. (Boston MA)

HIPAA Clarity 2012- ongoing (see Clients at hipaaclarity.com)

Owner/Independent Consultant. Assisted healthcare providers (doctors, clinics, etc.) and Business Associates meet the standards of the HIPAA Privacy Rule, HIPAA Security, and related regulations. Compliance work included the following services:

performed complete audits of healthcare operations, systems, and facilities

conducted security reviews, written gap analyses

recommended information technology (IT) updates and modifications

developed compliant policies and procedures

authored BA Agreements, Privacy notices, etc.

provided Awareness Training to healthcare staff

TopRX, Inc., Director, Software Development (2009 – 2012)

3950 Brother Blvd., Bartlett TN, 38133

IT director for a pharmaceutical distributor. Led software development for vendor’s ERP system, including work on warehouse, accounting and sales applications. Admin tasks included creating project plans, communicating results, and managing budget. Also hired and supervised programming staff of 12 FTE’s. Example software development projects included …

Enhancements for sales, warehouse, accounting, inventory mgmt, and EDI within ERP system, (ASW software by IBS http://www.ibs.net/)

New Customer Relationship Mgmt (CRM) system incorporating sales history, pricing strategies, account intelligence, etc.

New handheld computer barcode scanning device, incorporating dynamic pricing information

All corporate websites, including ecommerce

Accredo Health, Inc. – Sr. Manager, Software Development (2005 -2008)

1640 Century Center Parkway, Suite 101 Memphis, TN 38134

Managed software development projects related to healthcare products distribution. This involved authoring project charters, leading SLDC activities, illustrating transaction flows in Visio, scheduling code deliverables in MSProject, designing test routines, updating progress milestones, and verifying results with stakeholders. Direct reports included programming staff, web designers, e-commerce staff, DBA, etc. Managed budget of approx. $1M, excluding salaries.

Methodist Le Bonheur Healthcare –Manager, Internet Development (1997-2004)

850 Poplar Ave. Bldg 2, Memphis TN 38105

Served as lead Analyst on software development projects, including all corporate websites and custom web apps for a large healthcare system (9 hospitals). Created project charters, defined requirements, managed budgets, made schedules, built work diagrams, authored test plans, and communicated updates and results. Worked extensively with stakeholders and internal customers. Representative software projects included ….

Sentinel Events Reporting – archived nursing data, e.g. outcomes, sentinel events, labs, JCAHO etc..

Nurse Staff Scheduling – multi-user application used in 9 hospitals

Materials Management - automated the exchange of surplus clinical supplies among 9 hospitals.

Federal Express Corporation—Senior Technical Writer (1992-97)

Worldwide Communications & Policy Analysis Dept., 2710 Nonconnah Blvd., Memphis TN 38132

Guided publication of FedEx Best Practices and ISO9000 manuals. Coordinated initial research and planning work with engineering teams, completely wrote and designed publications, and managed printing and distribution of finished products to almost 115,000 employees worldwide. Ensured projects were on time and on budget.

Project leader for divisional Intranet Project. Directed teams across multiple departments to migrate corporate policy manuals to intranet. Effort required management of scope, requirements, schedule, communications and status reporting.

University of Maryland, Overseas Division—Instructor of English (1985 -91)

in Japan, Germany, and China. Im Bosseldorn 30, 6900 Heidelberg, GERMANY

Presented undergraduate English courses to U.S. military personnel stationed in Japan and Germany. Courses included Technical Writing & Editing, Business Writing, Advanced Composition, Library Research, etc. I have also taught undergraduate English course at Xian Medical University in China, the University of Memphis, State Technical Institute at Memphis, and the Memphis College of Art.

EDUCATION

University of Memphis, M.A., Major: English Rhodes College, B.A, Major: English

USA CITIZEN

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