Daniel Stoller Email & Phone Number

League City, TX, US

Geneva, CH

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

Geneva, CH

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.

Arlington, Virginia, US

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.

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.

West Conshohocken, PA, US

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

New York, NY, US

• 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.
• 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

Oslo, Norge, NO

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.

Oslo, NO

Quality systems and Regulatory consulting for medical device manufacturers.

Houston, Texas, US

• 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.

Pasadena, Texas, US

• 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.
• 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.

Roswell, GA, US

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

St. Louis, MO, US

• 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

Round Rock, Texas, US

• 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.

Sugar Land, TX, US

• 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.

London, GB