BSI Roadshow ISO 45001:2018

Engenheira Ambiental, com foco em Qualidade, Meio Ambiente, Saúde e Segurança do Trabalho. Mais de 15 anos de experiência profissional nas áreas da Qualidade, Meio Ambiente, Saúde e Segurança, atuando nos segmentos de Transporte Coletivo, Químicos e demais, papeleiro, metalúrgico, químico, automotivo, construção civil, florestal, petróleo e gás, alimentício e na área de educação como docente e coordenadora do curso Técnico em Segurança do Trabalho.

Patricia L. Murphy is the Global MDSAP Manager, at BSI, with responsibility for all aspects of the Medical Device Single Audit Program. Patty will be responsible for maintaining BSI’s leadership role as the MDSAP program moves from the Pilot Phase into the Operational Phase. This will be accomplished by continuing to develop the competence of our assessment staff to meet the needs of our customers.

Patty has worked in Medical Devices and Quality Assurance for over 25 years. Patty’s most recent role has been as VP of Quality Assurance and Regulatory Affairs for a US based Medical device manufacturer. Prior to that, she worked as Director of Quality Assurance, Principal Consultant and Certification Manager for a EU-based Certification Body.

Suzanne is Head of BSI Medical Device Notified Body. She has twelve years of experience within the Notified Body. For eight years Suzanne led the Orthopeaedic and Dental team, with responsibilities for aspects of EN ISO 13485 and CE Marking for all global clients. The team was also responsible under numerous Mutual Recognition Agreements for aspects of compliance in Canada, USA, Japan, Taiwan and Australia.

In her current role, she continues to audit manufacturers' quality systems and technical documentation while leading the global Medical Devices team.

Prior to Suzanne's work at BSI she completed a Bachelor Degree and Masters in Science (University of Waterloo) and a Doctorate in Engineering (University of Oxford).

Suzanne has worked in orthopaedic hospitals in Australia, Canada, Japan, UK and the USA, testing joint replacement implants and spinal and fracture fixation systems. She has also lead clinical investigations on orthopaedic implants.

Gary has over 25 years in the pharmaceutical and medical device industry with extensive knowledge of the United Kingdom healthcare environment the National Health Service (NHS) and Department of Health (DOH). His product expertise spans Interventional Cardiology, Cardiac Rhythm Management, Cardiac Surgery, and IV Therapy. Mr. Slack is responsible for P&L and strategic planning for BSI’s global medical device business with focus on the United States, United Kingdom, Germany, Japan, and China.

Stefan is the IVD Product Expert in the In Vitro Diagnostics Notified Body at BSI Healthcare. Dr. Burde has over 13 years of experience in the In Vitro Diagnostics Industry in the development and manufacturing of IVDs for US, European and global markets. His prior positions include Bayer Biological Products, bioMérieux, and Advanced Liquid Logic, as well as independent consulting work for IVD start-ups.

He joined BSI in 2014 as part of BSI’s expansion of the IVD team to address the growing need for Quality and Technical assessments by the IVD Notified Body in response to the upcoming changes to the European In Vitro Diagnostics Regulation.

Bill Enos is the Commercial Director, Medical Devices – Americas and has been with BSI for more than 13 years. Bill is now responsible for leading BSI activities in the medical devices regulatory sector for the Americas region including EU Notified Body, ISO 13485 Certification, Health Canada / SCC CMDCAS accreditation and MDSAP Auditing Organization recognition.

Previously Bill was the Global Head of Microbiology at BSI. His responsibilities include auditing quality systems and review of technical files and other certification activities related to sterile medical devices.

Before joining BSI, Bill was vice president for technical sales and business development at Microtest Laboratories, where he was involved with all aspects of medical device, pharmaceutical testing and manufacturing. Bill was with Microtest for eleven years and held several positions, including laboratory technician, laboratory manager, and director of quality systems, ultimately leaving after the vice president position.

Bill is a published author, BSI tutor and trainer, auditor, and technical specialist. Bill received his Bachelor of Science degree in microbiology in 1993 from Western New England University.

Paul has worked in the healthcare industry for over 35 years, joining bsi in August 2010 primarily to lead bsi’s effort in the Kingdom of Saudi Arabia where bsi had been designated by the SFDA as a Conformity Assessment Body under the SFDA MDMA Interim Regulations. Followed by project managing BSI’s implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Since October 2015 has been in a role working with both the Notified Body and the Knowledge Solutions business looking at how to optimise the knowledge, competencies and expertise in both organisations to position bsi as a “thought leader” for the medical devices and healthcare sector.

Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, and BOC Healthcare. His experience spans a broad range of medical devices including anaesthesia systems, patient monitors, ventilators, single use sterile disposables and devices for re-use, incubators, infusion pumps and surgical instruments.

Paul is a member of the Association of British Healthcare Industries (ABHI) Technical Policy Group and Convenor of the ABHI ISO TC 210 Mirror Group. He is Convenor of the BSI Committee which monitors all of the work undertaken by ISO TC 210, and was until recently Convenor of the BSI Sub-committee dealing with Quality Systems. As UK Delegation Leader to ISO TC 210, he is also actively involved in standardisation work of National, European and International Committees.

Paul has published articles in medical device industry journals, presents at conferences, and is a Module Advisor for an MSc program dealing with Regulatory Affairs for Medical Devices at Cranfield University.

Vicky has worked within the Medical Device industry for 18 years and is currently responsible for BSI's Quality Management System assessments that support BSI certification for CE Marking, ISO 13485 and related medical device schemes globally. With 9 years in the BSI Notified Body, Vicky's previous roles included Team Leader within the Orthopaedic & Dental Team and as a Technical Specialist / Scheme Manager conducting reviews of technical files and design dossiers. Prior to joining BSI Vicky worked for Johnson & Johnson for 9 years across a number of roles in a technical capacity, encompassing the R&D, manufacturing, quality assurance and regulatory aspects of a wide range of devices.