Easy Medical Device Podcast

https://www.youtube.com/embed/uN6EKR9vgUw?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We are talking a lot of time about how to be MDR certified and I provide you with some tips etc… In this episode of the Podcast, I wanted to interview someone that succeeded at EU MDR certification so we can get some story and secrets about what went well and what were some of the problems.

Shokoufeh Khodabandeh from Straumann in Switzerland is the EU MDR implementation lead and the team succeeded and received their EU MDR certificate. Shokoufeh will explain to us how they have done:

• How long did the project last?
• What are some of the issues that happened?
• What was the relation with the Notified Body?
• How was structured the team?
• What are some things that they would have done differently if they should restart?

This will be a really exciting episode as we get behind the curtain of a company that succeeded and they will explain how they have done it. I hope this will be helping other companies.

Who is Shokoufeh Khodabandeh?

Shokoufeh Khodabandeh is the MDR Implementation Lead at Institut Straumann AG, in Switzerland. Shokoufeh holds a Master’s of Science degree from the University of Toronto, and a Post Graduate Degree in Regulatory Affairs and Quality Assurance.

After the early career experience in IVDs and medical devices in the area of Prostate Cancer treatment in Canada, Shokoufeh moved to Switzerland as a Regulatory Affairs and Compliance Manager in the area of Dental Medical Devices, covering EU, USA, and Canadian submissions.

In her current role as the MDR Project Lead, Shokoufeh has spent the past year leading an interdepartmental project to identify the gaps in the existing QMS procedures and product documentation, and planning of the overall implementation strategy.

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

• Shokoufeh LinkedIn Profile: https://www.linkedin.com/in/skhodabandeh/
• Blog post Pitfalls on an EU MDR and IVDR project: https://easymedicaldevice.com/pitfalls-mdr-ivdr-projects/

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

The post The secrets to being EU MDR certified with Shokoufeh Khodabandeh 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.

Shokoufeh from Straumann in Switzerland is sharing with us her journey on the EU MDR world. She will tell us what helped the team to reach this success and what she would have changed. The post The secrets to being EU MDR certified with Shokoufeh Khodabandeh appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/6LYmTxb5VMA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Process Validation is a science but it needs also some education. In this episode of the Medical Device made Easy Podcast, we will help you understand what is Process Validation.

If you are a Medical Device Manufacturer or if you are an engineer that wants to understand Process Validation, then this episode is for you. We will talk with Adnan Ashfaq from Pharmi Med Ltd. He will share with us his experience and provide some valuable tips to be successful within this process.

Some of the topics we’ll cover are: – FAT SAT IQ OQ PQ – Prospective and retrospective validation – Soft skills to be a good Validation Engineer – What is the most common issue in a validation process? – Validation templates.

Don’t hesitate to contact Adnan Ashfaq to help you with your Validation Process.

He also proposes you to download his “Validation Toolkit”.

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/
• Blog post Process Validation or Verification: https://easymedicaldevice.com/medical-device-validation/
• Validation Toolkit to download: https://mailchi.mp/easymedicaldevice/81-process_validation

The post How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ) 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.

Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not following the instruction. Listen to Monir El Azzouzi and Adnan Ashfaq sharing with you their experience. The post How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ) appeared first on Medical Device made Easy Podcast.

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

In this episode of the Medical Device made Easy Podcast, Monir El Azzouzi will explain to you how to perform Internal Audits for your company.

Internal Audit is necessary to verify that your Quality Management System is compliant, efficient, and maintained. But how to do that, who can do that, when to do that…? It is also a requirement for ISO 13485, FDA QSR 21 CFR part 820.

And if you need some guidance to implement your Internal Audit process you can also use ISO 19011 to help you. All the answers will be here but remember that the Internal Audit process is also a powerful tool to increase Quality Culture within your organization.

You can use this tool also to convert your departments which are working in Silo to departments that are working together.

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

• Blog post on audits: https://easymedicaldevice.com/medical-device-audit/
• Green Belt Program EU MDR 2017/745: https://school.easymedicaldevice.com/courses-2/
• ISO 13485.2016: https://www.awin1.com/cread.php?awinmid=3911&awinaffid=506189&clickref=&ued=https%3A%2F%2Fshop.bsigroup.com%2FAffiliateRedirect.aspx%3Furl%3Dhttps%3A%2F%2Fshop.bsigroup.com%2FProductDetail%3Fpid%3D000000000030353196
• ISO 19011.2018 : https://www.awin1.com/cread.php?awinmid=3911&awinaffid=506189&clickref=&ued=https%3A%2F%2Fshop.bsigroup.com%2FAffiliateRedirect.aspx%3Furl%3Dhttps%3A%2F%2Fshop.bsigroup.com%2FProductDetail%3Fpid%3D000000000030354835
• FDA QSR 21 CFR part 820.22: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.22

The post How to execute your Internal Audits? (Medical Device companies) 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 episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it. The post How to execute your Internal Audits? (Medical Device companies) appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/VQTU4MTfDVo?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode of the podcast, we will review what happened during the month of May 2020 for the Medical Device Industry. And there was a lot.

The agenda:

• EU MDR non-anniversary
• The IVDR challenge
• The Coronavirus
• The Easy Medical Device surprise
• Notified Body Situation
• MDCG guidance
• What happened at Easy Medical Device

You can get all the link of all what we talked about below.

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. He has made is study in Biomedical Engineering at the ISIFC school in France which is specialized in all Medical Devices aspects for business. He held a brilliant career within major corporate companies like Johnson & Johnson, BBraun Medical, or Bausch + Lomb.

He always worked within Quality and Regulatory Affairs departments which brings him enough experience to support any organization. For that, he decided to create Easy Medical Device to support Medical Device manufacturers to bring compliant products on the market.

Additionally, his objective is also to help the Medical Device community to learn more about the Medical Device Regulation and Standard, and for that, he creates a blog, a YouTube channel, and a podcast where he educates all his followers.

Links

Hot Topics

• Erik Vollebregt Blog post: https://medicaldeviceslegal.com/2020
• MDR consolidated: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424
• EU MDR and IVDR implementing rolling plan: https://ec.europa.eu/docsroom/documents/41501?locale=en
• Standardization CEN CENELEC: https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=589#
• MIR Form: https://ec.europa.eu/docsroom/documents/41221/attachments/1/translations/en/renditions/native
• Covid 19
  • Switzerland: https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/mu500_00_014d_mb.html
  • Ireland: http://www.hpra.ie/docs/default-source/default-document-library/hpra-infographic-response-to-covid-19.pdf?sfvrsn=4
  • MHRA: https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-industry-and-manufactures-covid-19-tests-and-testing-kits
  • US FDA EUA: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Fake Certificates: https://www.team-nb.org/wp-content/uploads/2020/05/TEAM-NB-List-of-on-line-check-for-validity-of-certificates-20200514-1.pdf
• Greenlight Guru Virtual Summit – Economic Operators: https://youtu.be/6FF8H5W-NEw
• EU MDR Green Belt Certification Program: https://school.easymedicaldevice.com/product/green-belt-eu-mdr-certification-purchase/

Notified Bodies

• Vote Notified Body situation: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-eumdr-activity-6670306258815332352-9E4K
• Team NB Survey: https://www.team-nb.org/wp-content/uploads/2020/05/Team-NB-MD-Sector-Survey-PressRelease-20200505-1.pdf
• Notified Body Intertek Medical Sweden: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=34&ntf_id=306148

MDCG Guidance

• MDCG 2020-11 – Guidance on the renewal of the designation and monitoring of Notified Bodies under MDD, AIMDD (2020/666) https://ec.europa.eu/docsroom/documents/41421?locale=en
• MDCG 2020-10/1 Safety reporting in clinical investigation of Medical devices under the Regulation https://ec.europa.eu/docsroom/documents/41183?locale=en
• MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form https://ec.europa.eu/docsroom/documents/41184?locale=en

Podcast

• 75 – How to get your Digital Health Application reimbursed in Germany with DIGA (Stefan Bolleininger) https://podcast.easymedicaldevice.com/75/
• 76 – How to get ISO 13485 certified https://podcast.easymedicaldevice.com/76/
• 77 – What is the Notified Body Situation (Bassil Akra) https://podcast.easymedicaldevice.com/77/
• 78- What means Sufficient Clinical Data? (Bassil Akra) https://podcast.easymedicaldevice.com/78/

LinkedIn Live

• How to register Covid-19 Medical Supplies in the UK? (Helen Erwood) https://www.youtube.com/watch?v=GORGSHszH-E
• Medical Device Software: Sufficient Clinical Data under MDR and IVDR MDCG 2020-1 https://www.youtube.com/watch?v=HIycmCuBsi0
• How to comply with the GSPR? https://www.youtube.com/watch?v=iaE_gbhfW5U

The post Medical Device News – May 2020 Review with Monir El Azzouzi 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.

The Month of May 2020 was supposed to be the beginning of the EU MDR. This was not as the new date is on May 26th, 2021. We will celebrate the Non-Anniversary of it and also talk about IVDR, MDCG, Notified Bodies, Coronavirus, Easy Medical Device podcast, LinkedIn Live... So be ready and push play. The post Medical Device News – May 2020 Review with Monir El Azzouzi appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/plNtXt9UeX8?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

You are maybe trying to build your Clinical Evaluation Report or your PMCF for a Medical Device. And you are stuck because you don’t really understand what means Sufficient Clinical Data?

Then listen to this interview with Bassil Akra from QUNIQUE Group, who is sharing with us his experience as a former TÜV SÜD auditor.

He also participated in the different groups to prepare the guidance that we will discuss today.

During this interview we will discuss:

• The difference between MDD 93/42/EC or AIMDD 90/385/EEC and MDR 2017/745 in terms of clinical data
• The meaning of Sufficient Clinical Data
• The Essential Requirements or General Safety and Performance Requirements for Clinical Data
• The Product Equivalence chapter
• The PMCF rules
• The Expert panel

Bassil Akra will also present to us a Webinar that he will lead to help Medical Device manufacturers deal with the amount of data they should collect to pass an EU MDR audit.

The first session will be on June 8th for the EU time zone and June 11th for the US time zone. Another session will be planned for other timezones.

Who is Bassil Akra?

Dr. Bassil Akra, Co-owner and CEO of QUNIQUE Group has a background in research, development, regulatory approval, and quality management of medical devices.

Within his role at TÜV SÜD, Dr. Akra was a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020.

In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.

In his new role as Co-owner and CEO of QUNIQUE Group, he will now be also able to support Medical Device manufacturers through consulting and training.

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

Don’t hesitate to contact [email protected] for more information.

Links

• Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
• QUNIQUE Group: https://quniquegroup.com/
• QUNIQUE Training: https://quniquegroup.com/TRAININGS/
• MEDDEV 2.7/1 rev 4: https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native
• MDCG guidance 2020-6: https://ec.europa.eu/docsroom/documents/40904
• FREE PMCF Plan Template: https://school.easymedicaldevice.com/product/pmcf-plan-template/

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Telegram Channel: https://t.me/easymedicaldevice
• Youtube Channel: https://youtube.com/c/EasyMedicalDevice?sub_confirmation=1
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) 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.

Sufficient Clinical Data is a new vocabulary introduced with the EU MDR 2017/745 but this is still unclear what is sufficient and what is too weak. Bassil Akra from QUNIQUE Group will explain to you what you should do in the episode where a former Notified Body employee is giving you advises related to his experience. Bassil is also offering a webinar to people that want to learn more about sufficient clinical data. The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) appeared first on Medical Device made Easy Podcast.