Easy Medical Device Podcast

https://www.youtube.com/embed/q2_SnC1NIac?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We started to talk a lot about Brexit, but in the meantime for the Medical Device Industry, Swixit is starting to happen.

This is for Switzerland Exist from the European Union. But here we are not talking about the same exit as for the UK. Here we are talking only about the Medical Device industry.

Learn more in this episode of the Medical Device made Easy Podcast with Ronald Boumans from Emergo. He will explain to us what is happening to the Swiss market and what can be done to be ready.

Who is Ronald Boumans?

Ronald Boumans started his career as an industrial designer working in R&D designing smart packaging concepts. He has also had his own company importing medical devices from the far east into The Netherlands.

After that failed he worked for an organization researching the relation between quality of life and the use of medical devices. This brought him to a certification organization (TNO).

After that, he worked as a senior Inspector for medical technology for the Dutch Competent Authority. In 2013 he started working for Emergo as a senior consultant where he is now specializing in the European legislation and the political developments (e.g. Switzerland, Brexit).

He is also a board member of the European Association of Authorized Representatives (EAAR) which he represents at the European Commission in several Eudamed and UDI working groups.

Links

• Ronald Boumans LinkedIn: https://www.linkedin.com/in/ronald-boumans-34790055/
• Emergo website: https://www.emergobyul.com/
• Is Switzerland becoming a Third-Country: https://www.emergobyul.com/blog/2020/01/mdr-watch-switzerland-becoming-third-country
• Swiss Medtech Letter: https://3f523920-8cff-4a1c-8866-b188e9556a2b.usrfiles.com/ugd/3f5239_81ac77c6ade747c293171385b289b07b.pdf

The post Swixit or not Swixit? this is the question with Ronald Boumans 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.

Swixit or not Swixit? is an alert to Medical Device Manufacturers regarding the political game that is played between Europe and Switzerland. Let's see the impact for the Swiss market but also for the EU market. The post Swixit or not Swixit? this is the question with Ronald Boumans appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/OESAL-4fq4M?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

When you need to prove that your product conforms to the Specification, Process Validation or Verification is a good question you should ask yourself.

Monir El Azzouzi and Stefan Bolleininger will guide you so you can decide if you should perform validation or verification.

We will also present you with some tools and tricks to find some answers to your questions.

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…

Who is Stefan Bolleininger

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe.

He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections.

In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

Links

• AQL application: https://apps.apple.com/us/app/aql/id608818916
• Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• Monir El Azzouzi Linkedin: https://www.linkedin.com/in/melazzouzi/
• Process Validation or Verification Blog post: https://easymedicaldevice.com/medical-device-validation/

The post Medical Device School – Process Validation or Verification? 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 or Verification? Some people are mixing both concepts, this is why Monir and Stefan will help you understand when to use one or the other. The post Medical Device School – Process Validation or Verification? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/BLyJKV5EK9U?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, we will review all the major updates that happened in the Medical Device world.

I will try to gather the most important information and comment on them for you. This will also provide you the details of what happened on Easy Medical Device.

During this review, we will discuss the Guidances, standards, regulations that were released. We will also talk about the important news announced like Brexit or Switzerland MRA situation.

In the link section, I tried to gather all the sources for the information I provided so you can check that directly.

I am planning some LinkedIn Live. Don’t forget to follow me on LinkedIn (https://linkedin.com/in/melazzouzi) to be able to see when I am going live. I will also provide you the information when this will be planned. Usually on Friday at 3 pm CET.

Links

• MHRA Guidance: Clinical investigation – https://bit.ly/3iBvklQ
• MDCG Guidance: Cybersecurity – https://ec.europa.eu/docsroom/documents/38941
• CND Nomenclature information – https://ec.europa.eu/docsroom/documents/39007?locale=en
• ISO 14971:2019 standard: https://bit.ly/368Xvl0
• Bassil Akra opinion on Switzerland MRA situation: https://www.linkedin.com/pulse/my-personal-view-situation-switzerland-bassil-akra/
• Erik Vollebregt Blog post on Brexit: https://medicaldeviceslegal.com/2020/01/30/brexit-is-a-fact-now-deal-with-it/
• Bassil Akra Video (Linkedin link): https://www.linkedin.com/posts/wei-jiang-phd_tuvsudmdr-bassilakra-inspiretrust-activity-6628288507058106369-UCo3
• Episode 57 – PMCF with Helene Quie: https://podcast.easymedicaldevice.com/57/
• Episode 58 – 510k Registration with Michelle Lott: https://podcast.easymedicaldevice.com/58/
• Episode 59 – QMS compliant to MDR with Stefan Bolleininger: https://podcast.easymedicaldevice.com/59/
• Episode 60 – How to register your Medical Device in Brazil with Tania Aprigliano: https://podcast.easymedicaldevice.com/60/
• Medical Device School episode 4 – How to audit your suppliers? https://podcast.easymedicaldevice.com/mds4/
• Medical Device School episode 5 – Why is it awesome to work in QA RA? https://podcast.easymedicaldevice.com/mds5/

The post Episode 61 – Medical Device Regulatory Update: January 2020 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.

This episode will be dedicated to provide the regulatory updates that happened on January 2020. This will help you to stay up-to-date. The post Episode 61 – Medical Device Regulatory Update: January 2020 appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/ndcls6MDKCg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Are you considering Brazil as a country to register and distribute your Medical Devices? In this episode, we will give you all the information you need to make it easy for you and grow your business in this country.

Tania Aprigliano, will be my guest on this episode of the Medical Device made Easy Podcast and she will help us define what are the key steps you need to follow so ANVISA (Brazilian Agency) will authorize you to import your products to Brazil.

We will also discuss the advantage that you would have if you apply for MDSAP which means “Medical Device Single Audit Program”. This is a program that helps you to get certified to sell your products in 5 countries (USA, Brazil, Canada, Japan, Australia).

Who is Tania Aprigliano?

Professional with over 10 years of experience in product research and development, project management, technical documentation elaboration, and quality system implementation.

Acting in large multinational companies, in diversified segments as chemicals and medical devices.

Links

• Tania Aprigliano LinkedIn: https://www.linkedin.com/in/t%C3%A2nia-lobo-aprigliano-039672157/
• Blue Pipe Consultoria: https://www.bluepipeconsultoria.com/
• Presentation Brazil Registration: https://mailchi.mp/easymedicaldevice/brazil-registration
• ANVISA website: http://portal.anvisa.gov.br/medical-devices
• MDSAP article: https://easymedicaldevice.com/mdsap/

The post How to register your Device in Brazil with Tania Aprigliano? (ANVISA) 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.

As Tania is saying this is the best time to export your products to Brazil, so we'll teach you how to register your products there. Enjoy! The post How to register your Device in Brazil with Tania Aprigliano? (ANVISA) appeared first on Medical Device made Easy Podcast.

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

In this bonus episode of the Medical Device School, I asked Karandeep Badwal to tell us why a Quality and Regulatory Job in the medical device industry is awesome.

I know it’s not obvious but let’s see what Karandeep has as arguments. QA and RA do have bad press as these departments are considered to block projects or other things but maybe if you use another pair of glasses you will see the situation all other ways around.

If you are interested to know more about a Quality or Regulatory Affairs job, don’t hesitate to contact us.

Who is Karandeep Badwal?

Mr. Karandeep Singh Badwal is a Regulatory and Quality Professional specializing in medical devices.

His educational background is an MSc Pharmaceutical Quality by Design, however, he has worked almost exclusively within the medical devices industry from multinational companies to startups since his graduation.

Links

• Karandeep LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/
• A cheat sheet on how to be in QA RA: https://podcast.easymedicaldevice.com/wp-content/uploads/2019/07/Your-First-Job-In-Regulatory-Affairs.pdf
• Episode 31 – First Regulatory Affairs Job: https://podcast.easymedicaldevice.com/31/
• Article: https://www.linkedin.com/pulse/why-working-qa-ra-awesome-job-karandeep-singh-badwal/?lipi=urn%3Ali%3Apage%3Ad_flagship3_notifications%3BIkLSzW%2BkR1u4tlTpruhd5g%3D%3D

The post Why is it Awesome to work in a Quality or Regulatory affairs job? 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.

Quality and Regulatory affairs is not really a job that everyone want to work in. But this is maybe you didn't listen to the right arguments. Check what Monir El Azzouzi and Karandeep Badwal want to say. The post Why is it Awesome to work in a Quality or Regulatory affairs job? appeared first on Medical Device made Easy Podcast.