Is your company ready to manufacture a SaMD?
Join this training by registering below!
🗓️ Date: 17 September 2024
🕒 Time: 15:00 – 17:00 CET
What is this session about?
This training consists of three sessions about medical devices – quality management systems (EN ISO 13485:2016 + A11:2021):
- Webinar 1: Scope of application and first requirements (Tuesday, 17 September 15:00-17:00 CET) – OPEN FOR REGISTRATION
- Webinar 2: Resources management and product realization (Monday, 30 September 15:00-17:30 CET)
- Webinar 3: Measurement, analysis and improvement (Monday, 7th October 15:00-16:30 CET)
Note: We’ll notify you as soon as webinars 2 and 3 registration become available.
Webinar 1– EN ISO 13485:2016 + A11:2021: Scope of application and first requirements
- ISO 13485 scope overview, detailed explanations, and practical examples of the first requirements of the standard (QMS and Management Responsibility), highlighting their compliance with MDR.
Webinar 2– EN ISO 13485:2016 + A11:2021: Resources management and product realization
- Deep dive into Resources Management and Product Realization. Practical examples of how the requirements can be applied on a routine basis.
Webinar 3– EN ISO 13485:2016 + A11:2021: Measurement, analysis and improvement
- Deepen knowledge in Measurement, Analysis and Improvement of QMS in accordance with ISO 13485, through the explanation of the requirements and practical examples.
What will you learn?
Webinar 1
- To give participants a clear understanding of the 4th and 5th requirements of the standard EN ISO 13485:2016+A11:2021 and its link with MDR.
Webinar 2
- To give participants a clear understanding of the 6th and 7th requirements of the standard EN ISO 13485:2016+A11:2021 and its link with MDR.
Webinar 3
- To give participants a clear understanding of the 8th requirement of the standard EN ISO 13485:2016+A11:2021 and its link with MDR.
Who’s this session for?
- Collaborators of organizations involved in the design, production, installation, and servicing of software as medical devices.
- Professionals of the academy with health projects under development.
What will you receive?
- Slides
- Video recording
- Polls
Meet your Trainer(s):
Ana Abreu, Quality Assurance & Regulatory Affairs, Kinetikos Health
Ana Abreu has a degree in Biological Engineering, and a postgraduate degree in quality, environmental and safety management (ISO 9001, ISO 14001 and OHSAS 18001). With over 10 years of experience in regulatory affairs and quality management systems for medical devices, Ana has collaborated with Portuguese manufacturers of IVD-MD, metallic implants, surgical instruments, and synthetic bone grafts. Currently, is working in Kinetikos Health, a manufacturer of Software as a Medical Device.
Pedro Teixeira, Clinical Safety Officer, Kinetikos Health
Early on in his career, Pedro Teixeira had the opportunity to use his academic and clinical experience as a Physiotherapist to manage education and research teams around the world, that were adopting new technologies to perform their work. This led him to several different positions as a product developer, project manager and clinical consultant in many international institutions. In parallel, he was an invited Professor at Porto Medical School for more than 10 years and had the pleasure of lecturing at different postgrad courses and seminars all over the world. Currently, he’s responsible for product management & business development at Kinetikos Health, a digital health company specialised in assessing human movement and translating this information into clinical insight.
Rafaela Oliveira, Quality Control, Kinetikos Health
Rafaela Oliveira holds a degree in Clinical Physiology and a master’s in Bioinformatics and Biostatistics Applied to Health. With a background in healthcare, she spent two years working as a Clinical Physiologist on a research project, where she also contributed to the development and testing of an innovative mHealth tool. Rafaela successfully transitioned to the tech industry and now works at Kinetikos Health as a Quality Assurance Analyst, Business Analyst, and Scrum Master. Her responsibilities include manual testing of applications, developing detailed product requirements, and managing development tasks to drive project success and ensure high-quality products.