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Medical device manufacturers need effective quality management systems that meet global regulatory expectations and support safe, compliant products. ISO 13485:2016 is recognized internationally and is closely connected to European MDR and IVDR requirements through the standard’s European annexes.
This 5-day training introduces participants to the regulatory principles of medical device quality management and the requirements of ISO 13485:2016. Participants will learn the structure, content, scope, and exemptions of ISO 13485, how quality management connects to the medical device lifecycle, and how to support a process-oriented quality management system. This course is the first module in TÜV SÜD’s Quality Management in the Medical Device Industry continuing education program and forms the foundation for further qualification as a Quality Management Representative or Quality Auditor.
Dr. Elena Lucano is a dynamic Regulatory Affairs and Quality Assurance consultant with a proven track record of leadership and collaboration in medical devices and digital health. She has also experience working at t the Food and Drug Administration (FDA) where she performed regulatory science at the CDRH laboratories in Silver Spring (MD) focusing on the development of numerical models of Radiofrequency body coils for Magnetic Resonance Imaging for safety assessment on implanted patients. Adept at managing projects from startups to big corporates and spearheading high-impact initiatives across the EU, US, Switzerland, and UK, ensuring alignment with rigorous regulatory frameworks and industry standards.
Her engineering background gives her a robust foundation and understanding of the operation of medical devices, as well as aspects connected to their development and production. Elena joined Veranex in 2019, and over the years, she also got experience and insights on the aspect linked to the privacy of personal data, supporting with GDPR and HIPAA compliance activities.
Bruno Strappa
Manager, Quality and Regulatory Affairs
Bruno Strappa
Manager, Quality and Regulatory Affairs
Regulatory professional with over 12 years of experience in medical devices. Previously managed a start-up as CTO/QARA Responsible: developed QMS, managed V&V activities and performed regulatory submissions. Currently supports EU and US regulatory compliance projects for start-ups and multinationals. Experienced in SaMD (e.g., assessment of cardiac function through wearables/smartphones), AIMD (e.g., deep brain stimulation electrodes), combination products (e.g., pre-filled syringes) and IVD devices (e.g., urine selftests). Provides support in Risk Management, V&V, Software development, and Cybersecurity. Bruno is a certified auditor, fluent in English and Spanish.
Valentina Lintas
Manager, Quality and Regulatory Affairs
Valentina Lintas
Manager, Quality and Regulatory Affairs
Valentina is a biomedical engineer with a PhD in Integrative Molecular Medicine (University of Zurich, Switzerland) focusing on tissue-engineered heart valves for transcatheter aortic valve replacement. Following her doctoral studies, Valentina joined a med-tech start-up in the field of cardiovascular regenerative medical devices, where she was responsible for regulatory affairs. Valentina is a biomedical engineer with over seven years of experience in the medical device industry, specializing in regulatory and quality affairs. Valentina joined Veranex in 2021 and contributes to a wide range of regulatory and quality activities, including the drafting and critical review of technical documentation, development of regulatory strategies for EU, CH, and US markets, execution of QMS audits, and tailored support for quality system implementation and compliance with European medical device regulations.
Silvia Anghel
Sr Director Regulatory and Quality Affairs
Silvia Anghel
Sr Director Regulatory and Quality Affairs
Silvia brings robust scientific expertise in oncology, metabolic disorders, and gastroenterology, with a particular focus on biomarker discovery and detection. She has accumulated +15 years of experience in the healthcare industry, holding various roles within the field of In Vitro Diagnostics (IVD).
Throughout her career, Silvia has led projects across the full product lifecycle, from development and manufacturing to regulatory affairs and quality management, gaining a comprehensive understanding of the path from concept to commercialization.
She joined Veranex in 2019 and currently leads the European RA&QA team, providing strategic regulatory guidance to support the successful market entry of IVD/MD products.
Silvia holds a PhD in Molecular Biology and Genetics.
Paige Sutton-Smith is a Quality Management and Regulatory professional with 12 years track record in the medical device industry. Her expertise includes US regulatory approval, product design and development, process validations, V&V, complaint handling, QC strategies, QMS deployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced in maintaining QMS certification and FDA approvals for invasive and implantable products. Paige holds a BSc in Material Science and Engineering from Lehigh University (PA), achieved a RAC-Devices certification, is a Lean Six Sigma Black Belt, and ASQ certified as a Certified Quality Engineer.
Neville Rhodes
Manager, Quality and Regulatory Affairs
Neville Rhodes
Manager, Quality and Regulatory Affairs
Neville Rhodes is a Quality and Regulatory Affairs Manager based in Switzerland, with professional expertise supporting medical device compliance activities. At Veranex, he contributes to regulatory strategy, quality management, and client support for manufacturers navigating international regulatory requirements.
His experience includes regulatory submissions, quality system implementation, and lifecycle compliance aligned with global frameworks such as EU MDR and UK MHRA requirements. He supports clients through key processes, including technical documentation preparation, regulatory registrations, and post-market obligations.
Neville ensures that deliverables meet both compliance expectations and business objectives. He collaborates closely with cross-functional teams and stakeholders, providing clear guidance on regulatory pathways and quality requirements. Prior to joining Veranex, Neville held senior commercial and leadership roles in the coatings and chemicals industry, including Business Director EMEA at Axalta Coating Systems GmbH and Managing Director and National Sales Manager at Axalta Plascon (Pty) Ltd, where he led cross-functional teams and managed full P&L responsibility.
He later transitioned into the medical device and IVD field, completing a CAS in Clinical, Regulatory and Quality Affairs at FHNW University, and serves as a Runway Coach supporting Swiss start-ups in this sector.
Julianne Bobela
Scientific Affairs Director
Julianne Bobela
Scientific Affairs Director
Dr. Julianne Bobela is a Life Scientist with more than ten years of professional experience in the field of translational research applied to Neuroscience and more than five years of experience in Clinical, Regulatory, and Quality Affairs related to Medical Devices and IVDs. Her expertise includes conducting clinical evaluations for medical devices and performance evaluation for IVDs and preparing technical documentation and strategic planning for regulatory pathways. She is also an active member of the Veranex clinical team, supporting the setup, management, and final analysis of clinical studies on medical devices. Julianne is fluent in French, German, and English.
Cedric Razaname
Director, Quality and Regulatory Affairs - Head of QMS
Cedric Razaname
Director, Quality and Regulatory Affairs - Head of QMS
Cédric holds a master’s degree in Microengineering from EPFL Lausanne. He has previously worked in various companies in the field of manufacturing engineering and products development. Cédric is an expert in Quality and Regulatory Affairs for medical devices and IVDs, with over 8+ years of experience implementing quality management systems and managing regulatory submissions. He has experience working in heavy constraint environments, particularly in ISO 13485 QMS and ISO 27001 ISMS deployment, IEC 62304 software lifecycle management and cybersecurity support. Cédric speaks fluently English, French and has a good understanding of German.
Learn from Specialists Who Work Inside Medtech Complexity Every Day
Talk with Veranex about upcoming training dates, private sessions, or tailored programs built around your organization’s device, IVD, regulatory, clinical, or quality needs.
