Easy Medical Device Podcast

https://www.youtube.com/embed/6DaMJhtptZQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this monthly episode of the podcast, we talk about all that happened to the Medical Device industry. This is the July 2020 Update.

Within the Hot Topics, we will talk about the UK MHRA which warns about the “Certificate of Compliance” issued by certain certification bodies. We will also review the publication of the EU Commission regarding the PPE conformity assessment. And I will tell you the situation regarding the State of Play for the EU MDR.

Then we’ll review the Green Belt Certification Program. On the next topic, we will explain to you the situation of Notified Bodies. And some clarification on New Guidance and Standards. Don’t miss the clip regarding the Notified Bodies providing Pre-certification to their customers.

Finally, we’ll review what happened at Easy Medical Device these last weeks. Don’t forget to register for the Green Belt Certification Program.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

HOT TOPICS

• UK MHRA – Medical Device “Certificate of Compliance”/”Attestation of Conformity” https://www.gov.uk/government/news/medical-device-certificates-of-compliance-attestation-of-conformity-have-no-legal-standing-under-mdr
• Conformity Assessment procedure for Protective Equipment: https://ec.europa.eu/docsroom/documents/42311/attachments/1/translations/en/renditions/native
• State of play of EU MDR: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/implementationplan_en.pdf
• Green Belt Certification Program: https://school.easymedicaldevice.com

NOTIFIED BODY

• GMed : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43781
• NANDO EU MDR 2017/745: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
• NANDO EU IVDR 2017/746: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

GUIDANCE AND STANDARD

• ISO/TR 20416.2020 Medical Devices – Post-market surveillance for manufacturers: https://www.iso.org/standard/67942.html
• MDCG 2020-13 – Clinical Evaluation Assessment Report Template: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_clinical_evaluationtemplate_en.pdf
• MDCG 2019-6 v2 Question and Answers: Requirements relating to Notified Bodies https://ec.europa.eu/docsroom/documents/37688

PODCAST

• Episode 84 – How to become a PRRC with Team-PRRC https://podcast.easymedicaldevice.com/84/
• Episode 85 – Understand IEC 62304 with Adnan Ashfaq https://podcast.easymedicaldevice.com/85/
• Episode 86 – Learn UDI code with Sylvia Reingardt from GS1 https://podcast.easymedicaldevice.com/86/

LINKEDIN LIVE

• What can we learn from 100 Days of audits with Stefan Bolleininger: https://www.youtube.com/watch?v=-5bG_E7ndrs&feature=youtu.be

The post Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

In this monthly update we will review some hot topics that happened within the last weeks., the Notified Body Situation, the Guidance and standards update and finally what happened at Easy Medical Device. The post Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/7jErVlfmS4I?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The UDI code is a new feature introduced by the EU MDR 2017/745 and IVDR 2017/746. It is here to increase traceability and transparency with its combination to the EUDAMED database.

In this Episode, Sylvia Reingardt from GS1 (One of the UDI code Issuing entity) will help us to understand the requirements. She will also share some of the mistakes that she experienced.

Within this episode, Sylvia will also share with us some details about GS1 as a Non-Profit Organization. This organization is also providing training and share with the public a lot of material within its website.

Check links below which contains the pages where all the UDI code information is available. Sylvia shared with us also the emails and phone numbers if you want to call GS1 Germany for more information.

Who is Sylvia Reingardt?

She is a sector manager for Healthcare at GS1 Germany. Prior to joining GS1 Germany in October 2011, she worked for 10 years for a service provider by managing international EDI projects and she was also involved in the development and introduction of new services. Sylvia also spent more than 10 years in the area of procurement at two university hospitals.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

• Sylvia Reingardt Linkedin Profile: https://www.linkedin.com/in/sylvia-reingardt-3272262b/
• GS1 Germany UDI landing page: https://www.gs1-germany.de/gs1-complete/branchenangebote/udi-umsetzung-mit-gs1-standards/
• Basic UDI-DI tutorial (german version): https://youtu.be/28N9NZ7UOPY
• GS1 Germany – Training (inhouse, online, at GS1 Germany): https://www.gs1-germany.de/no_cache/gs1-academy/weiterbildung/?tx_gs1seminars%5Bcategory%5D%5B80%5D=true#c1397
• GS1 Germany Consulting – Email to [email protected]
• GS1 Global Office: https://www.gs1.org/industries/healthcare/udi
• Medtech Basic UDI-DI guideline: https://www.medtecheurope.org/resource-library/medtech-europes-guidance-on-basic-udi-di-assignment/
• Easy Medical Device Article on UDI: https://easymedicaldevice.com/udi
• Podcast Episode UDI: https://podcast.easymedicaldevice.com/4/

The post Learn UDI code for Medical Devices with Sylvia Reingardt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

UDI is new for Europe but already exist in the USA. We will explain to you what is important to understand for the EU version as there are some differences. Sylvia Reingardt from GS1 will be my guest and will share with us her knowledge and how GS1 can help. The post Learn UDI code for Medical Devices with Sylvia Reingardt appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/8UtCRFYe5XU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

If you are developing Medical Device software then IEC 62304 is an important standard for you. In this episode, Monir El Azzouzi invited Adnan Ashfaq from Pharmi Med Ltd to explain to us what is this standard.

He will also mention some key links to the EU MDR 2017/745 and to other standards. Here are some of the questions asked:

• Which medical device companies should use IEC 62304?
• Do I need to be a Software developer to be able to work on IEC 62304?
• What is the difference between software classification provided by IEC 62304 and EU MDR 2017/745?

Adnan is offering also a document to download which will help you during your projects with this standard.

Who is Adnan Ashfaq?

Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech, and Pharmaceutical industries.

Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits.

He has been working with start-up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Adnan Ashfaq Linkedin: https://www.linkedin.com/in/adnan-ashfaq-44478121/
• Pharmi-Med Ltd: https://www.pharmi-med.com/
• SaMD audit template: https://mailchi.mp/easymedicaldevice/iec62304
• MDCG 2019-11: https://ec.europa.eu/docsroom/documents/37581
• IMDRF guidance on SaMD: http://www.imdrf.org/workitems/wi-samd.asp
• IEC 62304 standard (affiliate): https://tidd.ly/2Bfjz4a
• Episode 81- Process Validation with Adnan Ashfaq: https://podcast.easymedicaldevice.com/81/

The post Understand IEC 62304 for Medical Device Software with Adnan Ashfaq appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

What is IEC 62304? This is the question I asked Adnan Ashfaq from Pharmi Med Ltd. The answer is helping a lot to understand the interaction with other standards and regulations. Enjoy it! The post Understand IEC 62304 for Medical Device Software with Adnan Ashfaq appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/KRDp_uuSvYU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The PRRC is a new role within the EU MDR 2017/745. All medical device companies need a person within their organization to be responsible for that. In this episode, I have invited Team-PRRC which is a non-profit association that is representing the PRRC roles. They are here with me to explain more about it and also explain what are some of the difficulties. Within this session, Elem Ayne (President of Team-PRRC) and Anne Jury (Vice-President of Team-PRRC) accepted to answer my questions and will also share with you what Team-PRRC can do for you.

In this episode, Elem and Ayne will also mention the fees to be part of the association. They have a special offer until May 26th, 2021 which is the date of application of EU MDR.

Who is Elem Ayne?

Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of “DM Experts” network (in France).

She has started her career in R&D in microbiology, oncology, and biochemistry. She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality, and regulatory affairs for different industries, in particular in sterilization.

She has finally specialized herself in Regulatory affairs working especially in Class I reusable granted by a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745.

She is also the President of the Non-for-profit association Team-PRRC

Who is Anne Jury?

Anne Jury is a consultant in medical device regulatory affairs and quality management systems in the business she founded in 2000.

Before that, she was a lead auditor and area manager working for notified bodies, BSI and then TUV Sud, covering manufacturers large and small in Europe and North America for seven years. Her early career started out with a large medical device technology manufacturer where she was company microbiologist responsible for the release of all sterile devices in the days before CE marking even existed for medical devices.

In her current role, she works mostly with small start-up companies getting new quality systems implemented and developing the regulatory strategy for gaining market access for innovative new devices.

It is in this role that she has realised the potential challenges to be faced by the PRRC in micro and small enterprises and therefore happily accepted the invitation to become the Vice-president of Team-PRRC.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

Now, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Elem Ayne LinkedIn profile: https://www.linkedin.com/in/elemayne/
• Anne Jury LinkedIn profile: https://www.linkedin.com/in/anne-jury-1967546/
• Team-PRRC website: https://www.team-prrc.eu/
• Podcast Episode 36: How to choose your PRRC with Erik Vollebregt: https://podcast.easymedicaldevice.com/36/
• Blog Post PRRC: https://easymedicaldevice.com/prrc/

The post How to become a PRRC with TEAM-PRRC (EU MDR & IVDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Team-PRRC is invited to this episode to help us understand how to become a PRRC. This is a new role required for Medical Device manufacturers. In this episode, we will also share with you what TEAM-PRRC can do to help you. The post How to become a PRRC with TEAM-PRRC (EU MDR & IVDR) appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/IrdZAGBSV8I?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In the Medical Device News segment of the podcast, we will talk about what happened during the month of June. Each month we imagine that there is not a lot to say but each month we get some surprises. On the Agenda we have:

• The Coronavirus situation for Medical Device Supplies
• The MDR IVDR rolling plan. This includes a trailer for a Telenovela
• The Green Belt Certification Program
• The Notified Bodies Situation
• New Standards and MDCG Guidances
• What happened at Easy Medical Device

All the links for the sources of the information provided are on the below section

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

Hot Topics

• Notified Body Covid 19 survey- https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_survey-conformity-assess-covid-19.pdf
• List of Covid19 Essential Medical Devices (MDs and IVDs): https://www.team-nb.org/wp-content/uploads/2020/06/NBM-036-20-List-of-COVID-19-essential-Medical-Devices-final.pdf
• Covid19 In Vitro Diagnostic Devices and Test Methods Database: https://covid-19-diagnostics.jrc.ec.europa.eu/devices/2#form_content
• MDR and IVDR implementation measures rolling plan: https://ec.europa.eu/docsroom/documents/41501?locale=en ­
• Erik Vollebregt Blog post: https://medicaldeviceslegal.com/2020/06/20/standardisation-request-for-mdr-and-ivdr-refused-now-what/
• LinkedIn Post on CEN CENELEC refusal of Harmonized Standard Mandate: https://www.linkedin.com/posts/mariogabriellicossellu_mdcg-standards-ugcPost-6679841091816095744-Vn7Z
• Green Belt Certification Program: https://school.easymedicaldevice.com/shop/

Notified Body Situation

• IVDR: TÜV SÜD Product Service GmbH Zertifizierstellen: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=307788&version_no=19

Standard and Guidance

• ISO/TR 24971:2020. https://www.iso.org/standard/74437.html
• MDCG 2019-16 Guidance on Cybersecurity for Medical Devices https://ec.europa.eu/docsroom/documents/41863?locale=en
• MDCG 2018-3 Rev 1 Guidance UDI for systems and procedure packs: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance_udi_spp.pdf
• MDCG 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues: https://ec.europa.eu/docsroom/documents/41622?locale=en

Podcast – LinkedIn Live

• Episode 80: How to execute an Internal Audit https://podcast.easymedicaldevice.com/80/
• Episode 81: How to perform Process Validation for Medical Devices: https://podcast.easymedicaldevice.com/81/
• Episode 82: The Secret to be EU MDR certified: https://podcast.easymedicaldevice.com/82
• How to be the best at CAPAs – Karandeep Badwal: https://youtu.be/zWK1U7d2awY

The post Medical Device News – June 2020 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

During this update, we will talk about the Coronavirus situation, the Notified Body accredited, the CEN CENELEC mandate for Harmonized Standards, the Green Belt Certification Program. A lot to say and also a Trailer for the EU Commission Telenovela. The post Medical Device News – June 2020 Update appeared first on Medical Device made Easy Podcast.