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Date: 16th - 17th of November 2023
Key poins:
We are delighted to invite you to take part in the Annual Medical Devices Regulations & Safety 2023 Conference, which will take place on the 16th — 17th of November 2023 entirely online.
The Annual Medical Devices Regulations & Safety 2023 Conference will gather industry experts from various geographical regions from all around the world and provide an outstanding learning and networking platform to discuss the latest challenges, novel applications, innovations, and trends in the Medical Devices and In Vitro Diagnostic Sectors.
The conference will provide you with the unique opportunity to foster progress by facilitating knowledge sharing and building ongoing collaborations.
The event would be beneficial for various professionals and stakeholders involved in the medical device and in vitro diagnostic industries, as well as regulatory bodies. Here are some key individuals and organizations who should consider joining the conference:
Medical Devices Regulations & Safety 2023 Conference conference aims to provide a comprehensive overview of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and their impact on the medical device and in vitro diagnostic industries. The conference will cover various aspects related to the regulations, including key requirements, implementation challenges, compliance strategies, and best practices.
The conference sessions will feature renowned speakers, experts, and industry leaders who will share their insights, experiences, and expertise on navigating the complexities of the MDR and IVDR. They will discuss the regulatory changes, timelines, and implications for manufacturers, notified bodies, regulatory authorities, and other stakeholders.
Attendees will have the opportunity to gain a deep understanding of the MDR and IVDR, including the updated classification system, conformity assessment procedures, clinical evaluation and investigation requirements, post-market surveillance obligations, and labeling and UDI requirements. The sessions will also cover the specific requirements and challenges related to in vitro diagnostic devices under the IVDR.
The conference will provide a platform for knowledge sharing, where attendees can learn about successful strategies and practical approaches to achieve compliance with the MDR and IVDR. Case studies and real-world examples will be presented to illustrate best practices and highlight potential pitfalls to avoid.
In addition to the educational sessions, the conference will offer networking opportunities for attendees to connect with industry peers, regulatory experts, and representatives from notified bodies. This will enable participants to exchange ideas, share experiences, and establish collaborations to address the common challenges posed by the MDR and IVDR.
Overall, the Medical Devices Regulations & Safety 2023 Conference will serve as a valuable resource for professionals and organizations seeking to understand and navigate the regulatory landscape, ensure compliance, and drive progress in the medical device and in vitro diagnostic sectors.
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Michael is dedicated to the digitalization and automation of regulatory processes and technical documentation. After working at Fresenius Kabi, he founded meddevo.com in 2018 to finally offer dedicated software for regulatory departments.
Richard Houlihan is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions.
His company EirMed with the website Eudamed.com provide ongoing EUDAMED and regulatory submissions consultancy, support, training, a EUDAMED mobile search app, and software to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their EUDAMED data submissions.
Ella Helgeman is an accomplished Regulatory and Quality Director with over 20 years of experience in the medical device industry and Notified Body. With a Master’s degree in Electrical Engineering and an MBA, Ella has gained a deep understanding of the regulatory, clinical, technical and quality requirements for the medical device industry. Throughout Ella`s career, she has been instrumental in the successful development, launch, and commercialization of numerous medical devices. Ella has also been involved in the development and implementation of quality management systems in compliance with various international regulations. As a renowned industry expert, Ella has presented at numerous conferences and seminars on regulatory and quality matters. With her expertise in the medical device industry, Ella brings a wealth of knowledge to the table and is highly regarded in the industry. Ella`s passion for the medical device industry has led to her involvement in numerous industry associations and committees, including RAPS, Team NB, NBCG-Med and Team PRRC. She is dedicated to the advancement of the industry and is committed to ensuring that medical devices are safe and effective for patients worldwide.
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 17 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant in the market. His passion for the Medical Device field pushed him to create educative content like blogs, podcasts, YouTube videos, and LinkedIn Lives where he invites guests who are sharing educative information with his audience. Visit easymedicaldevice.com to know more.
Dr. Lucretia Hardiman is an accomplished professional driven by a deep passion for quality. With a Ph.D. in Biochemistry from the prestigious National University of Ireland Galway, Lucretia embarked on a successful career in the diagnostics field. However, it was her transition into the medical device industry that ignited her fervour for quality management.
Currently serving as the Global CAPA Program Lead at Teleflex, Lucretia leverages her extensive expertise to drive impactful change through Corrective Action and Preventative Action (CAPA). With her wealth of knowledge and experience, she offers valuable insights into the intricacies of quality management.
In her upcoming talk, Lucretia will delve into the crucial realm of Root Cause Analysis Tools, with a particular focus on the CAPA Investigation phase. Drawing upon her deep understanding of this critical area, she will provide practical strategies and techniques to identify and address the underlying causes of quality issues effectively.
Through her engaging presentation style and ability to communicate complex concepts, Dr. Lucretia Hardiman inspires and empowers professionals across industries to elevate their quality management practices.
Hooman is currently the Senior Lead Auditor for BSI under MDSAP, EU MDR, MDD, and ISO 13485. Previously Hooman worked as the Technical Leader and Engineering Conformity Assessor at the Therapeutic Goods Administration (TGA) the medical devices regulator of Australia. Hooman has a PhD in mechanical engineering from University of New South Wales (UNSW Australia).
