Podcastblaster Podcast Directory  Podcast Directory

Podcast Search   
Podcast title Medical Device made Easy Podcast
Website URL https://podcast.easymedicaldev...
Description Listen Medical Device Regulation and Standards
Updated Sun, 18 Aug 2019 14:02:22 +0000
Image Medical Device made Easy Podcast
Category Business
Education
Government & Organizations
Science & Medicine
Subscribe

Vote for this podcast
    Currently 0.00/5

Rating: 0.0/5 ( votes cast)

Link to this podcast Medical Device made Easy Podcast

Episodes

1. Episode 37 – Usability & Human Factor with Sharon Ayd
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Let's not talk about theory but really about experience when we are looking for Usability tests and Human Factors. Sharon Ayd will share with us a project where she was able to use these notions to succeed.

The post Episode 37 – Usability & Human Factor with Sharon Ayd appeared first on Medical Device made Easy Podcast.



2. Episode 36 – How to choose your PRRC with Erik Vollebregt
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

PRRC means Person Responsible for Regulatory Compliance. With the new Medical Device Regulation it is mandatory to have one at your company. Let's review everything about this role and help you to choose the right person.

The post Episode 36 – How to choose your PRRC with Erik Vollebregt appeared first on Medical Device made Easy Podcast.



3. Episode 35 – Digitalization of QA RA with Michael Kania
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Digitalization of QA RA is a concept that many Medical Company didn't adopt. But what can they win if they engage on it? This is the topic of today´s episode.

The post Episode 35 – Digitalization of QA RA with Michael Kania appeared first on Medical Device made Easy Podcast.



4. Episode 34 – Real-World Data for Medical Devices with Alethea Wieland
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Real World Data is more and more important with all the new devices that can collect them. Then what can we do with them and how to present them to a regulator.

The post Episode 34 – Real-World Data for Medical Devices with Alethea Wieland appeared first on Medical Device made Easy Podcast.



5. Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

One important piece of the puzzle for the new Medical Device Regulation is about Notified Bodies. More and more we receive the information that some of them decide to Lay Down Service. What are the consequences for manufacturers? What is a solution for them? Erik Vollebregt will be my guest on this episode.

The post Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt appeared first on Medical Device made Easy Podcast.



6. Episode 32 – Pakistan Registration Process with Muhammad Sohail
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Pakistan Registration requirements for Medical Devices have been improved and leave more opportunities for Manufacturers. Muhammad Sohail, will share with us the situation of this market and the steps to register your products.

The post Episode 32 – Pakistan Registration Process with Muhammad Sohail appeared first on Medical Device made Easy Podcast.



7. Episode 31 – First Regulatory Affairs Job with Karandeep Badwal
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Finding your first Regulatory Affairs Job can be a challenge. And Karandeep Badwal knows about that as he followed this journey. He is now Regulatory Affairs Contractor. Karandeep wanted to share with the audience some tips to be able to find quickly your first job. So don't miss those actionable tips.

The post Episode 31 – First Regulatory Affairs Job with Karandeep Badwal appeared first on Medical Device made Easy Podcast.



8. Episode 30 – Promotional Compliance with Darshan Kulkarni
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products.

The post Episode 30 – Promotional Compliance with Darshan Kulkarni appeared first on Medical Device made Easy Podcast.



9. Episode 29 – 5 Steps to create a QMS with Jason Lim
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Jason Lim will reveal to us what are the 5 steps to create a good Quality Management System or QMS.

The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Device made Easy Podcast.



10. Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

How an OEM or Original Equipment Manufacturer can help the OBL (Own Brand Labeller) to continue business? Stefan Bolleininger from Be-On-Quality will help us on this second part of the Podcast.

The post Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2 appeared first on Medical Device made Easy Podcast.



11. Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

The OEM and OBL model is under question with the new EU MDR and IVDR regulations. Stefan Bolleininger will help us understand how to continue to be compliant and continue business.

The post Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1] appeared first on Medical Device made Easy Podcast.



12. Episode 26 – IVDR preparation with Andreas Stange
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Andreas Stange from TÜV SÜD will help us be prepared for the new IVDR or In-Vitro Diagnostic Regulation. This is a game changer for the manufacturers as more products are on the scope of a notified Body certification.

The post Episode 26 – IVDR preparation with Andreas Stange appeared first on Medical Device made Easy Podcast.



13. Episode 25 – EUDAMED secrets with Richard Houlihan
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

EUDAMED is the new European Database for Medical Devices and this is something that can change completely the world of Medical Devices. For the consumers and the manufacturers.

The post Episode 25 – EUDAMED secrets with Richard Houlihan appeared first on Medical Device made Easy Podcast.



14. Episode 24 – Myths about consultants with Thomas McMann
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Are you hiring contractors or consultants for your projects? Do you know the difference or do you know what are the myths about them? Thomas McMann from EPM Scientific is sharing that with us.

The post Episode 24 – Myths about consultants with Thomas McMann appeared first on Medical Device made Easy Podcast.



15. Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your clinical trial project.

The post Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland appeared first on Medical Device made Easy Podcast.



16. Episode 22 – Clinical Trial with Alethea Wieland
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation? I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding. She will help beginners in this area to learn about the fundamentals of clinical trials.

The post Episode 22 – Clinical Trial with Alethea Wieland appeared first on Medical Device made Easy Podcast.



17. Episode 21 – How to master Regulatory Affairs with Samantha Alsbury
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to be experimented they should start somewhere. So how to do that? Samantha Alsbury from TOPRA will help us on this new episode.

The post Episode 21 – How to master Regulatory Affairs with Samantha Alsbury appeared first on Medical Device made Easy Podcast.



18. Episode 20 – What is a Blockchain with Khuram Malik
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Blockchain for Healthcare is a new Technology. On this episode, Khuram Malik will tell us what is Blockchain and how Medical Devices can use it.

The post Episode 20 – What is a Blockchain with Khuram Malik appeared first on Medical Device made Easy Podcast.



19. Episode 19 – Rule 11 for Software Devices with Cyrille Michaud
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Cyrille Michaud from MD101 Consulting is helping us to understand the new rule 11 to classify Software Devices in the European Union. This is a new rule so this creates a lot of discussion in the industry. Let's clarify that with Cyrille.

The post Episode 19 – Rule 11 for Software Devices with Cyrille Michaud appeared first on Medical Device made Easy Podcast.



20. Episode 18 – QA RA Recruitment situation with Petra Ognjenovic
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Is it the right moment to move to another position if you are in Quality and Regulatory affairs? Petra Ognjenovic from SciPro Global is helping us to decode the situation on the recruitment market. She will also provide us some tips to find the right candidate.

The post Episode 18 – QA RA Recruitment situation with Petra Ognjenovic appeared first on Medical Device made Easy Podcast.



21. Episode 17 – Unannounced audit stories with Florent Guyon
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

On this new Episode, Florent Guyon from Nexialist is sharing with us his anecdotes regarding unannounced audit. He will also talk to us about a Master Degree he proposes at the ISIFC Biomedical Engineering School

The post Episode 17 – Unannounced audit stories with Florent Guyon appeared first on Medical Device made Easy Podcast.



22. Episode 16 – From Disease to a Medical Device with Sean Hamilton
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Sean Hamilton from War on Epilepsy is a Seanpreneur as he says on this episode. He is epileptic and this made him think that he can maybe create a Medical Device for people with the same condition. So he founded War On Epilepsy. Listen to his story which provides a great message.

The post Episode 16 – From Disease to a Medical Device with Sean Hamilton appeared first on Medical Device made Easy Podcast.



23. Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

On this second part of the podcast episode, Erik Vollebregt is continuing to tell us more stories on the background of the MDR and IVDR. We'll discuss about the differences between big and small companies and also the brexit, notified bodies and finally rule 11 for the classification of Software

The post Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2 appeared first on Medical Device made Easy Podcast.



24. Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1)
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Erik Vollebregt from Axon Lawyer is explaining to us what is the EU MDR and IVDR. This will be a 2 part episode with a lot of anecdotes. Erik is also the author of the blog MedicalDevicesLegal.com

The post Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast.



25. Episode 13 – Brexit Talk with Richard Young
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Richard Young from Sensus group talk to us about the Brexit Situation. His company is located in the UK and is helping Medical Device manufacturers to overcome this situation. Brexit date is planned on March 29th, 2019 and for now there is no deal reached.

The post Episode 13 – Brexit Talk with Richard Young appeared first on Medical Device made Easy Podcast.



26. Episode 12 – How to create an ISO Standard with Marcelo Antunes
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Marcelo Antunes from SQR Consulting is walking us through the process of Standard creation. You'll understand how you can participate to it and why it is so important. We will also discuss about the Elsmar Cove Forum that is a great source of support.

The post Episode 12 – How to create an ISO Standard with Marcelo Antunes appeared first on Medical Device made Easy Podcast.



27. Episode 11 – Medical Device Software Validation
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Bill Stamm and Rafael Blanco from General Digital Software Services are helping us to understand Medical Device Software Validation. This process is becoming more and more important as the Healthcare business is transitioning to digitization.

The post Episode 11 – Medical Device Software Validation appeared first on Medical Device made Easy Podcast.



28. Episode 10 – Understand MDSAP with Angelina Hakim
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

On today’s show, I invited Angelina Hakim the CEO of Qunique which is an Agency helping customers on Regulatory projects and also provide some service as an auditor. She has […]

The post Episode 10 – Understand MDSAP with Angelina Hakim appeared first on Medical Device made Easy Podcast.



29. Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Show Notes This episode of the Medical Device made Easy Podcast is special as this is the first one I am doing with a guest. I have interviewed Ivan Perez […]

The post Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro appeared first on Medical Device made Easy Podcast.



30. Episode 8 – From Correction to Prevention with ODIAC
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Learn one of the many methods to move your working area from Correction to Prevention with the ODIAC method. Don't try to find it on Google because I created it only for you. Learn how to solve issues before they come to your desk.

The post Episode 8 – From Correction to Prevention with ODIAC appeared first on Medical Device made Easy Podcast.



31. Episode 7 – Make your KPIs Green again
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

KPIs means Key Performance Indicators. This is an important part of the Quality Management System of a company. This is not specific to Medical Devices but you have to have […]

The post Episode 7 – Make your KPIs Green again appeared first on Medical Device made Easy Podcast.



32. Episode 6 – What are the 6 types of Medical Device Audits
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

On this episode of the Medical Device made Easy Podcast I will tell you what are the 6 Types of Medical Device Audits. I know that when you are talking about audit on your companies, there are some kind of Panic Mode. Or maybe you are more "Always Audit ready". So listen to learn more on audits.

The post Episode 6 – What are the 6 types of Medical Device Audits appeared first on Medical Device made Easy Podcast.



33. Episode 5 – Medtech Prediction 2019
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

2019 is here and as I read many media´s predictions for the medtech industry, I decided to also predicte myself what will be a trend. I will talk specifically about 2 axes which are Technologies and Regulations. Both are linked because as regulators we need to understand the technologies to be able to provide the right answer when we need to issue a regulation.

The post Episode 5 – Medtech Prediction 2019 appeared first on Medical Device made Easy Podcast.



34. Episode 4 – UDI for Unique Device Identification
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

UDI for Unique Device Identification. You will need to understand what is happening with the UDI to be able to implement it. So let´s learn first about the vocabulary.

The post Episode 4 – UDI for Unique Device Identification appeared first on Medical Device made Easy Podcast.



35. Episode 3 – Is my Product a Medical Device in Europe?
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Medical Device made Easy Podcast Episode 3- On this episode I help you to define if your product is a Medical Device in Europe? I know it sounds basic but you´ll see that the new Medical Device Regulation MDR 2017/745 is changing the rules. So listen carefully.

The post Episode 3 – Is my Product a Medical Device in Europe? appeared first on Medical Device made Easy Podcast.



36. Episode 2 – New EU Medical Device Regulation MDR 2017/745
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

The new EU Medical Device Regulation MDR 2017/745 will be in place by May 26th, 2020 but are you already aware of its content. Listen to this episode to know more.
I provide you some information the timeline for the application of the MDR and also the changes that happen. On the resources, I link to a blog post I created on this topic. And as a gift, I propose you to download an Alexa Skill to tell you how many days remains until the new Medical Device Regulation is live.

The post Episode 2 – New EU Medical Device Regulation MDR 2017/745 appeared first on Medical Device made Easy Podcast.



37. Episode 1 – Introduction to the Medical Device made Easy Podcast
http://feedproxy.google.com/~r... download (audio/mpeg, 0.00Mb)

Description:

Within this first episode of the Medical Device made Easy Podcast I am introducing myself and also this podcast. Don´t forget to subscribe to it so you can be notified when a new episode is released.

The post Episode 1 – Introduction to the Medical Device made Easy Podcast appeared first on Medical Device made Easy Podcast.