A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build one. We will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it with your compliance duties. Check this and share it with your team.  Who is Lesley Worthington?  Lesley works with individuals and teams to fine-tune their Quality conversations, initiatives, and internal communications to create a better understanding of the role and concepts of quality a ..read more

The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Quality or Regulatory affairs activities.   Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device community.  Who is Erik Vollebregt?  Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences ..read more

If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant.  Who is Adam Isaacs Rae?  Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction in ..read more

Sponsor: Medboard: https://www.medboard.com/ EU MDR and IVDR national languages update – France accepts English MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pdf Which devices for Expert Panel – Active Implantable Device on Top: https://health.ec.europa.eu/document/download/4c43abea-b989-434b-9ac1-94134bf1a538_en?filename=md_annual-overview-cecp-2022-2023_en.pdf 94.4% for Cl ..read more

Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field.  Who is Cesare Magri?  Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with ..read more

The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified.  Who is Steve Curran?  Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market.  He has a broad range of experience from general medical devices to orthopaedic and dental devices and ..read more

The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution?  Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR.  Who is Naveen Agarwal?  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the ..read more

EU EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/ Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf Spain: AEMPS consultation – Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificaci ..read more

In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR transition periods. So apparently this is urgent and needed to avoid shortage. Let’s ask Erik Vollebregt what he thinks about it. Will this really help and when will this become a law as it is only a proposal for now.  Who is Erik Vollebregt?  Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life science ..read more

When you are willing to sterilise your Medical Devices, you maybe think of EtO or Ethylene Oxyd as the method. So if you are on that case, there is a potential change that will happen and we want to alert you about that.  Christina Ziegenberg from BVMed is answering my questions and will explain to us the situation. So don’t miss this episode.  Who is Christina Ziegenberg?   Dr. Christina Ziegenberg can look back on a distinguished career in medical technology, the chemical industry and pharmacy. With an education at the HBLVA for Chemical Industry in Vienna, a diploma in pharm ..read more