Medical Device made Easy Podcast easymedicaldevice

I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to this to be an expert in Usability. 



Who is Amandine Broussier ?



Amandine Broussier is an independent medical devices usability specialist who supports medical device manufacturers in their usability engineering process (EN 62366-1:2015). She has 8 years of experience in the usability engineering, working with around 30 manufacturers on different devices (hardware, software) (class II, class III and IVD). 



Amandine can help you through all stages of the usability engineering process including auditing your current usability documentation with recommendations for improvement, identifying of use-related risks, writing the different documents required by the EN 62366-1 standard, and carrying out your formative and summative evaluations for CE marking and FDA approval. She also provides introductions to usability engineering for companies to help them understand the expectation of notified bodies with regards to usability standards.  



  



Who is Monir El Azzouzi? 



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 16 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 on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 



Link 



Amandine Broussier Linkedin Profile: https://www.linkedin.com/in/amandine-broussier-888a41113/ 



IEC 62366-1 link: https://www.iso.org/fr/standard/63179.html 



IEC 62366-1/A1 link: https://www.iso.org/fr/standard/73007.html 



IEC 62366-2: https://www.iso.org/fr/standard/69126.html 



Social Media to follow



Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi



Twitter: https://twitter.com/elazzouzim



Pinterest: https://www.pinterest.com/easymedicaldevice



Instagram: https://www.instagram.com/easymedicaldevice

Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions. 



Who is Vincent Cafiso ? 



Named as one of MD+DI's 24 Medtech Voices to Follow in 2024, Vincent Cafiso is a former U.S. FDA Investigator with 30-years of medical device and in vitro diagnostics (IVD) industry experience and is currently the Founder and Managing Consultant for his firm Practical Compliance Results. Vincent prepares his clients to be ready for their next FDA inspection and Notified Body audit consulting in the areas of compliance, quality assurance, and quality systems. 



  



Who is Monir El Azzouzi? 



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 16 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 on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 



Link: 



Vincent Cafiso Linkedin Profile: https://www.linkedin.com/in/vincentcafiso/ 



CREO Consulting Website: https://creoconsulting.com/ 



Social Media to follow



Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi



Twitter: https://twitter.com/elazzouzim



Pinterest: https://www.pinterest.com/easymedicaldevice



Instagram: https://www.instagram.com/easymedicaldevice

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 endeavors. Prior to acquiring Vonco in December of 2012, he served as a General Manager of Carbonless Rolls and Security Papers for Appleton Papers, the largest division of a $1BN paper company. Keith holds a bachelor’s degree in industrial engineering as well as an MBA from Northern Illinois University and Lean and Six Sigma certifications from the University of Michigan.  



  



Who is Monir El Azzouzi? 



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 16 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 on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 



Link 



Keith Smith Linkedin Profile: https://www.linkedin.com/in/keith-smith-725508b/  



Keith Smith Website: https://keithsmith.io/  



Social Media to follow



Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi



Twitter: https://twitter.com/elazzouzim



Pinterest: https://www.pinterest.com/easymedicaldevice



Instagram: https://www.instagram.com/easymedicaldevice

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 executive leadership team at Zuper. Michael has worked in customer and field service for more than 40 years. He spent 20 years in his early career managing both domestic and international field service operations, including 12 years with IBM’s Field Engineering organization. Over the past three decades, he has held management and executive roles with major providers of CRM and Field Service software applications, including tenures with IFS, Oracle, and SAP.   



His broad experience includes marketing, selling, supporting, and implementing CRM and Field Service software applications. Michael also served as a Field Service analyst for Aberdeen Group, the Technology Services Industry Association (TSIA), Jolt Consulting, and the Service Council. 



  



Who is Monir El Azzouzi? 



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 16 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 on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 



Link



Michael Israel Linkedin Profile: https://www.linkedin.com/in/michaelisrael1/ 



Zuper Website: https://zuper.co 



Social Media to follow



Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi



Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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?filename=mdcg_2024-4_en.pdf

Form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F54cbbfd4-5808-4560-93ef-017f2a3b0f41_en%3Ffilename%3Dmdcg_2024-4_appendix_en.xlsm&wdOrigin=BROWSELINK

MDCG 2024-5 Guidance – SInvestigator's Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf

Checklist 2024-5 https://health.ec.europa.eu/document/download/a387e3e7-65e3-4af5-bb98-2281949feded_en?filename=mdcg_2024-5-appendix-a_en.docx

 Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=

 

 

 Team-NB: ESMINT initiative –  Call for expert: https://www.team-nb.org/esmint-initiative/

 Spain AEMPS Bulletin on Health Products –  From Jan - March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan

 Germany: Classification - Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html

 Swiss: SaMD –  information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf

Turkey: 26 May 2024 –  Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706

 

Article to read

European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf

 

Training

Training EU MDR –  Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/

 Malaysia training –  Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI

Team-NB training  -  IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/

 

Events

 Events –  Check Medtech Conf: https://MedtechConf.com

 

Rest of the world

 South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do

 South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)

 South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1

 Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0

 Australia: Consultation on IFU –  Call for more flexibility: https://www.tga.gov.au/resources/cons

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 assurance throughout their organization. 



  



Through her leadership and executive coaching, she supports professionals as they work on improving their relationships and effectiveness in their roles allowing them to achieve their fullest potential, professionally, and empowering them to move their organizations toward a robust Quality Culture. 



She runs a community, The Quality Network, which supports Quality professionals as they work on the skills that allow them to build a Quality Culture. The Quality Network is a place for learning, coaching, support, and networking and includes webinars, resources, a member platform, courses, and office hours.  



  



She combines 20 years of quality and regulatory experience in medical devices, in Canada, with thousands of hours of teaching and coaching to provide her clients with the skills, techniques, insights, and mindset that raise their confidence, take their communication skills to the next level, and allow them to have a positive impact in their organizations. 



  



She’s got a Psychology Degree, a Law Degree, English as a Second Language Teaching Qualifications, and is a Certified Executive Coach. 



Who is Monir El Azzouzi? 



Monir El Azzouzi, a distinguished expert in the medical device sector, holds a Biomedical Engineering degree from ISIFC in France. With extensive experience at top-tier companies such as Bausch+Lomb, Aesculap, and Johnson & Johnson, Monir has a deep understanding of the industry’s challenges and opportunities. His commitment to enhancing industry standards and support led him to establish Easy Medical Device. 



Easy Medical Device is an innovative company dedicated to enriching the medical device community through educational outreach such as podcasting, blogging, and video creation. The company also offers specialized training programs, notably the Green Belt Certificate for EU MDR, to elevate professional skills within the industry. 



Beyond education, Easy Medical Device provides comprehensive consulting services, helping manufacturers navigate the complexities of CE Marking, FDA registration, clinical evaluation reports, internal audits, design and development, supplier reviews, eQMS implementation, and due diligence. Our expertise extends to acting as authorized representatives and importers in Europe, Switzerland, and the UK, facilitating smoother market entry for our clients. 



Monir's vision for Easy Medical Device is to establish it as the definitive one-stop shop for all services related to medical device manufacturers. We are committed to assisting you in introducing and advancing your projects with efficiency and compliance. 



Do not hesitate to contact Monir El Azzouzi at Easy Medical Device to explore how we can support your medical device initiatives. 



Links



LinkedIn: https://www.linkedin.com/in/lesleyworthington/ 



Website: https://lesleyworthington.com/  



Email: lesley@lesleyworthington.com  



Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice



Instagram: https://www.instagram.com/easymedicaldevice