How to select and evaluate your Contract Manufacturer? 
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
1w ago
Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your supplier and not the legal manufacturer of the product. So now the question is how to select them and also how to handle them. Let’s find that out with Keith Smith from Vonco  Who is Keith Smith?  Keith Smith is the President and CEO of Vonco Products. Keith has a passion for cultivating infectious energy, innovation, and creation. He generously contributes time and resources to entrepreneurial, education, athletic, and health ..read more
Visit website
Quality Field Service for Medical Devices
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
2w ago
Michael Israel from Zuper.co is helping us understand the world of Field Service and then we can understand better how some information collected by Field Service Engineer can help Quality Department to have a better operation. Collect machine performance, train technicians, identify issues.   Michael will also talk about Zuper which is a FSM software (Field Service Management) and can help you save time and collect the write information. So don’t hesitate to check his website.  Who is Michael Israel?  Michael Israel is Vice President of Community and a member of the execu ..read more
Visit website
Medical Device NewsMAY 2024 Regulatory Update
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
3w ago
EU Notified Bodies TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1 MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en ..read more
Visit website
Why and how to build a Quality Culture?
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
1M ago
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
Visit website
What is the impact of AI Act on Medical Devices? 
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
1M ago
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
Visit website
Radiation Sterilisation Master File (ISO 11137 & 11607) 
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
1M ago
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
Visit website
Medical Device News April 2024 Regulatory Update
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
1M ago
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
Visit website
How to benefit from Surveys to build Clinical Evidence?
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
2M ago
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
Visit website
How to do Postmarketing Surveillance the right way? 
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
2M ago
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
Visit website
Learn more about FDA QMSR alignment with ISO 13485
Medical Device made Easy Podcast
by melazzouzi@easymedicaldevice.com (Monir El Azzouzi), Monir El Azzouzi
2M ago
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
Visit website

Follow Medical Device made Easy Podcast on FeedSpot

Continue with Google
Continue with Apple
OR