Convenor for ISO Technical Committee 210/Working Group 6 (Application of post market surveillance systems to medical devices).

Member of the following ISO Technical Committees/Work Groups:ISO/TC 210/WG 1 (Application of quality systems to medical devices)ISO/TC 210/JWG1 (Joint Working with IEC/SC 62A : Application of risk management to medical devices)ISO/TC 210/WG7 (Good engineering maintenance management)

• Providing regulatory guidance, research, and quality system consulting services to medical device and biologics developers• Conducting internal audits, mock external audits, and gap assessments applying ISO 9001, ISO 13485, ISO 14971, MDSAP and other requirements• Developing and implementing regulatory strategies for market introduction• Supporting and preparing pre-market applications such as 510(k), PMA, and CE Mark. • Providing US FDA Authorized Agent services.

Working group member for the following standards-related groups:QM - WG01 Application of quality systems to medical devicesQM - WG02 General aspects from application to medical devicesQM - WG04 Application of risk management to medical devicesQM - WG06 Application of post market surveillance systemsQM - WG07 Good Engineering Maintenance ManagementSM – WG 01 Software Working GroupSM – WG 05 Device Security Working GroupArtificial Intelligence Committee

Quality management and regulatory consulting for medical device and manufacturing applications. Services include US FDA product registration, Quality Management System development and implementation and audits to various standards and regulations. Also a supplier of ISO 13485:2016 and MDSAP Lead Auditor services.

Voting Committee Member for the following groups:E11 Quality and StatisticsF04 Medical and Surgical Materials and DevicesF42 Additive Manufacturing TechnologiesD13 Textiles

WP Group provides management systems and regulatory consulting services. We work across various industries with a special focus on high risk areas such as aerospace, defense, and medical devices. We specialize in implementing management systems standards including:• Aviation Space and Defense Quality Management Systems: AS9100, AS9110, AS9120 • Quality Management Systems: ISO 9001, ISO 13485, API Spec Q1• Risk Management Systems: ISO 14971• Environmental Management Systems: ISO 14001• Information Security Management Systems: ISO 27001

Quality management and regulatory consulting for medical device and manufacturing applications. Services include US FDA product registration, Quality Management System development and implementation and audits to various standards and regulations. Also a supplier of ISO 13485:2016 and MDSAP Lead Auditor services.

Quality systems and Regulatory consulting for medical device manufacturers.

• Responsible for corporate compliance to applicable Quality and Regulatory requirements for the global organization.• Managing global product GTIN and DI registration.• Managing Quality Assurance and Regulatory Affairs for the global organization including QA/RA staff and contractors at distribution and manufacturing facilities based in the United States and China.• Managing the global Quality Management System (QMS) including the CAPA and risk management processes, and product return and complaint handling processes.• Creation and management of rework processes.• Creation and management of contract manufacturer specifications and processes.• Prepare product type approval applications for notified and regulatory bodies.Key Accomplishments• Prepared FDA 510(k) and MDD and PPE Directive submissions for CE Mark.• Defined and directed product testing to international standards.• Developed MDR compliance program for global operations.• Created Regulatory and Quality strategy for global operations.

• Responsible for compliance to applicable Quality, Health, Safety and Environmental (HSE) regulations and standards for Fischer-Tropsch waxes and petroleum byproducts at manufacturing and R&D facilities.• Responsible for development and implementation of Quality Management Systems manufacturing and R&D facilities.• Worked with Production, Operations and Technology areas of the companies to plan and implement a product testing laboratory at the manufacturing facility while developing and implementing improvements to the R&D laboratory. • Promoted, developed and oversaw compliance of the company Quality Management and Health, Safety and Environmental Systems to applicable requirements.• Managed policies, standards, procedures, programs and practices while driving and facilitating continuous innovation and improvement.• Supported plant sites with quality and incident root cause analysis, problem solving, and lessons learned exercises, while driving continual improvement.• Assisted sites with development of corporate quality policies, auditing practices and ensuring adherence to company’s quality and regulatory strategies in accordance with the established strategic plan.• Managed product Safety Data Sheets documents for all product lines across four business units.Key Accomplishments• Developed the Quality Management System and best practices for the QMS and other management systems.• Developed methods for data collection and extracting data. Prepared reports on statistics and trends using them to improve areas of concern. Created Quality and HSE metrics and reporting data and reported them to upper management.

• Performed Quality Management System and ISO 13485 MDSAP compliance activities for a medical device manufacturer in the Greater Houston Area.

• Responsible for quality of all product lines, compliance to applicable ISO, OSHA, ASME, CSA and UL regulations and standards.• Managed quality assurance for manufacturing site producing $12.5 million worth of process management systems annually.• Developed quality metrics program to allow company to measure product and manufacturing process performance. There was no metrics program previously.• Managed RMA process and handled customer product issues to resolution.• Prepared and coordinated product type approval applications for notified bodies such as UL, CE, CSA and CRN.• Provided leadership and training in techniques such as CAPA, problem solving, process improvement, health and workplace safety.Key Accomplishments• Developed and implemented standardized procedures for evaluating product quality at various steps of the product fulfillment process where no procedures and documentation had previously existed. Improved product return rate from 24,000 ppm to 12,000 ppm over 14 months.• Implemented documented reviews of product nonconformances and conducted root cause analysis on product field issues. This had previously been an ad hoc process.• Developed and implemented supplier quality management system.• Created and presented material on risk management and ISO 9001:2015 transition to Emerson Automations Solutions personnel worldwide.

• Responsible for product quality and compliance to applicable ISO, FDA and State of Texas, regulations and standards for $10 million in annual production.• Established and maintained document control and incident reporting systems for the company.• Prepared and submitted product type approval applications for notified bodies and regulatory authorities.• Developed company quality goals and objectives for strategic planning.Key Accomplishments• Established Risk Management System and Quality Management System framework for ISO 13485 and FDA compliance.• Developed standardized document templates and quality checklists where there was no documentation previously.• Oversaw transition of the quality operations from Houston, TX, to a new manufacturing facility in Round Rock, TX.

• Responsible for product quality of flow computing technology and compliance to applicable ISO, IEEE, API, UL and CE regulations and standards.• Managed six employees manufacturing $28 million worth of product annually.• Managed Quality, Administration, Human Resources and Information Technology departments.• Participated in new product design reviews, focusing on manufacturability, product testing and regulatory issues.• Performed research on potential customers in the midstream petrochemical market to support the Sales group.• Prepared, submitted and attained product type approvals from notified bodies, including UL, CE, GOST and INMETRO.• Developed company quality goals and objectives for strategic planning.Key Accomplishments• Developed and implemented the company Quality Management System, including quality policies, procedures, work instructions and supplier quality system. No systems had existed previously.• Improved unit first pass rate from 46% to 92% in 7 months by implementing final inspection program.• Achieved ISO 9001 certification for the company’s Quality Management System.