Medical Device made Easy Podcast easymedicaldevice

You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy.

Who is Richie Christian?

Richie Christian has more than 10 years of experience in medical device regulatory and quality. He has a Master’s degree in neurophysiology from the University of Auckland, and is passionate about digital transformation of the healthcare industry. Throughout his career, Richie has worked in numerous regulatory and quality roles with not only traditional hardware device manufacturers, but also cutting-edge AI/ML-enabled SaMD manufacturer.

In his most recent role as the Head of Regulatory and Quality, he spearheaded the development and implementation of a streamlined QMS, enabling them to achieve MDSAP certification and secure market authorisations for an innovative orthopaedics AI/ML-enabled SaMD in USA and Japan.

Richie relocated to Basel, Switzerland from New Zealand as a consultant for wega Informatik where he now applies his decade-long experience to help companies develop and deliver compliant medical device software. 

 

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.

Links

·      Richie Christian Linkedin Profile: https://www.linkedin.com/in/christianrichie/

·      Wega Website:  https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance

·      AAMI/BS standard https://knowledge.bsigroup.com/products/application-of-iso-14971-to-machine-learning-in-artificial-intelligence-guide?version=standard

·      Good Machine Learning Practice for Medical Device Development: Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

·      Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles

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

 

If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authorities… So stay tuned. 



Who is Thomas Lommatzsch? 



Thomas LOMMATZSCH heads the Medical Business Unit of AFNOR Certification, which deals with the certification of medical devices within the notified body AFNOR Certification (NB0333). With over 20 years' experience within Notified Bodies under various European regulations, he has completed several notification projects, most recently the AFNOR Certification notification project under the MDR. Thomas is also involved in standardization work relating to the application of the AI Act, particularly with its application to medical devices. 



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



Thomas Lommatzsch Linkedin Profile: https://www.linkedin.com/in/thomas-lommatzsch/ 



AFNOR webpage: https://certification.afnor.org/qualite/marquage-ce-dispositifs-medicaux 



EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320 



EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320 



French competent authority ANSM: https://ansm.sante.fr/ 



JAT Joint Assessment: https://health.ec.europa.eu/document/download/b9d671f5-02d0-44b1-a207-b07aeb4ef931_en?filename=md_info_ja_mdr_en.pdf 



MDCG 2022-13 Designation, re-assessment and notification of conformity assessment  



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

Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers. 



Who is Heena Thakkar? 



Heena Thakkar is a regulatory consultant currently working with Alceon Medtech Consulting. She is based in Gujarat, India. Heena is qualified in risk management, design controls, usability engineering, clinical evaluation, clinical trial management, quality management systems and process validation. She is also a certified internal auditor.  



Heena has around 8 years of experience in the field of regulatory affairs and quality management system for medical devices. She is experienced in regulatory submissions for vast range of devices ranging from orthopaedic devices, endovascular devices, single-use consumables, ophthalmic devices and wound care devices. She also conducts external trainings in the areas such as risk management, quality management system, EU MDR and EU IVDR.  



  



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: 



Heena Thakkar Linkedin Profile:  

https://www.linkedin.com/in/heenathakkar?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_appAlceon Medtech Consulting Website:  

https://alceonconsulting.com

List of standards helpful for cleaning validation of reusable instruments  



ANSI/ AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices https://www.aami.org/standards/featured-standards/aami-st98  



USFDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (https://www.fda.gov/media/80265/download) 



ISO 17664-1:2021: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (https://www.iso.org/standard/81720.html) 



ISO 15883-1:2006: Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (https://www.iso.org/standard/41076.html) 



ISO 15883-5:2021: Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (https://www.iso.org/standard/68297.html) 



ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3208-20.html) 



ASTM F3293-18: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3293-18.html) 



There are many additional standards that manufacturers will need to refer to in addition to the ones listed above. Contact us at contact@alceonconsulting.com for additional information or service inquiry. Thank you

 

EUROPEEU MDR 26 May 2024 - Was there any apocalypse:

France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition

Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering

EU shortage managed - EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320

EMA Q&A on Combination products - Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf

EU talks about SoHo -: Substances of Human Origin

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356

https://www.consilium.europa.eu/en/press/press-releases/2024/05/27/council-adopts-new-rules-on-substances-of-human-origin/

Italy Database error - Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569

Ireland guide on In-House IVDs - Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8

Combined Studies in the EU - COMBINE PROJECT:

https://ec.europa.eu/newsroom/sante/items/830485/en

https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf

Notified Bodies

Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf

Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf

New Notified Bodies for EU MDR –

MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1

Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18

QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1

 

UKUK on international recognition - Approve products without CE or UKCA mark: 

https://www.gov.uk/government/news/mhra-announces-a-proposed-framework-for-international-recognition-of-medical-devices

https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices

UK implementation of Future Regulation - When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations

UK Common Specifications for IVD - Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices

UK suspected counterfeit Medical Device -  How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device

UK Ai Airlock - Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence

Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217

 

Easy Medical Device:

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