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”.

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.

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…

• Adnan Ashfaq Linkedin: https://www.linkedin.com/in/adnan-ashfaq-44478121/

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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.

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…

• Blog post on audits: https://easymedicaldevice.com/medical-device-audit/

The post How to execute your Internal Audits? (Medical Device companies) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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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

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

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.

Hot Topics

• Erik Vollebregt Blog post: https://medicaldeviceslegal.com/2020

Notified Bodies

• Vote Notified Body situation: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-eumdr-activity-6670306258815332352-9E4K

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

Podcast

• 75 – How to get your Digital Health Application reimbursed in Germany with DIGA (Stefan Bolleininger) https://podcast.easymedicaldevice.com/75/

LinkedIn Live

• How to register Covid-19 Medical Supplies in the UK? (Helen Erwood) https://www.youtube.com/watch?v=GORGSHszH-E

The post Medical Device News – May 2020 Review with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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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

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.

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.

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.

• Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/

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

The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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You are looking for a Notified Body for your Medical Device in the EU market but you don’t understand why this is so difficult. In this episode of the Medical Device made Easy podcast, I have invited Dr. Bassil Akra, the VP of Strategic Business Development at TUV SUD. TUV SUD is one of the biggest Notified Body in the World.

Bassil will explain to us the current situation with Notified Bodies while we have a pandemic where Notified Bodies cannot perform on-site audits but also while we have a 1-year delay for the EU MDR application. So we hope that this episode will answer all your questions and that you will understand why getting an MDD 93/42/EC or AIMDD 90/385/EEC certification is something that is not easy anymore. You will understand also why during the next months you will not be able to issue a new certificate for a new Medical Device.

We will also talk about the “Devil” regulation which is renewing the accreditation of Notified Bodies without following the normal route. And you will understand why it is called the Devil regulation.

In the end, Bassil will also explain to you how it is to work at a Notified Body and all the benefits that you can get. Don’t forget to check the links below for more help.

Dr. Bassil Akra, Vice President of Global Strategic Business Development for TÜV SÜD Product Service has a background in research, development, regulatory approval, and quality management of medical devices.

Dr. Akra is 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.

Dr. Akra presents worldwide on European requirements and is involved in the development of many guidance documents and standards.

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…

For any Quality or Regulatory Affairs projects, please contact us through the EasyMedicalDevice.com website.

• Dr. Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/

The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi