Easy Medical Device Podcast

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.

Episode 12 – ISO Standards Creation with Marcelo Antunes

On the Medical Device made Easy Podcast I invited Marcelo Antunes from SQR Consulting to help us understand how the ISO standards we are using are created. Do you know how ISO 13485, ISO 14971 are created? Who is deciding which rules to apply? Are you also angry because some of the requirements doesn’t make sense?

Marcelo Antunes will tell us everything. You’ll know how to create standards and also how YOU can participate in the creation of a Standard which is really important for manufacturers.

We will also discuss about the Elsmar Cove Forum that exist since 1996 and which is a great source of support for the Medical Device industry.

Marcelo Antunes Biography

Marcelo Antunes is a Regulatory affairs strategy consultant at SQR Consulting, São Paulo, Brazil. He has more than 18 years of experience in the medical devices field.

The focus of his work is in thecompliance of the medical device during it’s lifecycle, based on regulationsand standards. He is an expert in Brazilian regulations and CE marking ofmedical devices. He also works regulations worldwide.

He’s chairman of the Brazilian mirror to ISO TC 210 (Quality management and general aspects of medical devices) and ISO TC 194 (Biological and clinical evaluation of medical devices). He’s an expert member, appointed by Brazil,  of all working groups of ISO TC 210 (quality systems, risk management, software, usability, symbols, and nomenclature) and ISO TC 194, and also some IEC committees, at the international level. He’s a member of RAPS and manager of the RAPS Brazil Network and maintains the Medical Device Expert News blog. He’s also a teacher of medical device development and regulatory affairs at a number of Brazilian universities.

Links

• Marcelo Antunes Linkedin: linkedin.com/in/marceloantunes
• SQR consulting Brazil: http://www.sqrconsulting.com.br/
• The 4-hour workweek (Tim Ferris): https://amzn.to/2EEEdtv
• Medical Device Expert News: http://www.medicaldevice.expert/
• ISO website: https://www.iso.org
• https://www.iso.org/publication/PUB100037.html – My ISO job – What delegates and experts need to know
• https://www.iso.org/directives-and-policies.html – Directives and policies (including ISO/IEC Directives parts 1 and 2)
• https://elsmar.com/elsmarqualityforum/ – Elsmar Cove Forum

https://www.youtube.com/embed/AHl5ZMoOdYY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 12 – How to create an ISO Standard with Marcelo Antunes 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.

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.

Medical Device made Easy Podcast – Episode 11 – Medical Device Software Validation

Bill Stamm and Rafael Blanco from General Digital Software Services are helping us to have a better understanding of Software Validation. This topic is critical for Medical Device Manufacturers as the Healthcare world start to get digital.

More digital products that contain a software, more software on the manufacturing side, more software to verify software. I mean, software are everywhere.

The new EU MDR is strengthening the requirements for Software and we need then experts to help. Bill and Rafael are specialized on this and they are the right SMEs to tell us exactly which mistake to avoid.

I will also ask them about artificial intelligence as this is a kind of software that is more complicated.

They also asked me to share with you some documents like the V-shape which describe the software validation process. Don’t hesitate to download it on the resource section.

All the details to contact Bill and Rafael are below so don’t hesitate.

Background

About Bill Stamm
Mr. Stamm is the Vice President of Software Services at General Digital Corporation. He leads the Software Services team in sales and business management, growing global customer relations and partnerships, and oversees all software development, certification, IV&V testing and documentation. Mr. Stamm joined General Digital in 2015. With over 25 years of experience in the field, his varied background has brought him from service and engineering into sales and marketing. Mr. Stamm has also owned several businesses and has worked as an international sales and marketing manager at various other technology companies, such as EMC and Practical Automation. Mr. Stamm holds degrees in Computer Engineering, as well as Business Administration and Management.

About Rafael Blanco
Mr. Blanco has extensive experience with Software Verification and Validation of Avionics systems and components. He has performed verification (integration testing, module testing, reviews) on Bleed Air Systems, Mechanical Actuators, Fuel Pumps, Fuel Tanks & Systems, Automatic Flight Control Systems, Engine Controls, Starters, Pneumatic Systems Equipment, Cooling Systems, Fly-by-Wire Systems and Flight Management Systems. With over 25 years of experience in testing and project management, he has successfully brought his customers through FAA (Transport Canada, JAA) certifications for DO-178 projects both as a Verification Engineer and a Project Manager.

About General Digital Software Services
The General Digital Software Services business unit has over 45 years of extensive software development, certification and testing expertise—including Independent Validation & Verification (IV&V)—in the most stringent safety critical environments in the world: medical (FDA, IEC62304, PMAs and 510(k)), industrial controls (IEC 61508, IEC 61131), aerospace & avionics (DO178), and pharmaceutical and general packaging and robotic equipment. Our services can encompass the full software life cycle from development to verification, or simply help with overflow work.

Resource

General Digital Software Services: http://gdsoftwareservices.com

Bill Stamm Linkedin:
linkedin.com/in/bill-stamm-64118113

Rafael Blanco Linkedin:
linkedin.com/in/rafael-blanco-54963836

Document PDF to download: Link 1 and Link 2

Medtech prediction 2019: https://podcast.easymedicaldevice.com/5

FDA – General Principles of Software Validation: https://www.fda.gov/downloads/MedicalDevices/…/ucm085371.pdf

https://www.youtube.com/embed/tkgB7O7qXl4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Youtube Video – Episode 11 – Medical Device Software Validation

The post Episode 11 – Medical Device Software Validation 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.

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.

Episode 10 – Understand MDSAP with Angelina Hakim

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 12 years of experience in Medical Devices with manufacturers and consulting organization. She is MDSAP and ISO 13485 certified.

She will explain us how to get MDSAP certified and how to avoid certain pitfalls.

MDSAP stands for Medical Device Single Audit Program and this is a new way to get certified for companies that are selling products to the USA, Australia, Japan, Canada, and Brazil.

This is a recent program that helps manufacturers to get audited only once instead of many times by each organization.

Below was an infographic I created for one of my article on my blog Easy Medical Device.

Infographichttps://easymedicaldevice.com/mdsap/Qunique

QUNIQUE provides medical device companies with customized solutions for quality management systems (QMS), supporting the implementation of new processes and training personnel appropriately.

QUNIQUE focuses on compliance and efficiency. Its services cover the whole range, from creating a template or a standard operating procedure (SOP) to implementing a full QMS in compliance with ISO 13485:2016, Medical Device Single Audit Program (MDSAP), US Food and Drug Administration (FDA) 21 CFR part 820, or ISO 9001:2015.

QUNIQUE understands the regulatory requirements for medical device manufacturers, including the EU medical device regulation (MDR), MDSAP, and the ISO 13485:2016.

Video

https://www.youtube.com/embed/erj7O62A4ec?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Video Podcast EpisodeResources

Qunique website: https://www.qunique.ch

Angelina LinkedIn:
linkedin.com/in/angelina-hakim-34b70225

Book recommendation Homo Deus: https://amzn.to/2UcomYl/

Easy Medical Device Article: https://easymedicaldevice.com/mdsap

Episode 6 – What are the 6 types of Medical Device Audits

The post Episode 10 – Understand MDSAP with Angelina Hakim 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.

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.

Medical Device made Easy Podcast Episode 9 – Ivan Perez ChamorroPodcast Episode 9 – Entrepreneurial Journey with Ivan Perez ChamorroShow 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 Chamorro on his journey as entrepreneur on the Medical Device business.

Biographie

Ivan Perez Chamorro is CEO and Founder of MedBoard
(www.medboardco.com) , a technology company that organises medical devices information, make it fast accessible, integrated, and useful, and create the tools that companies and professional need. This medical devices’ information includes primarily, regulatory affairs and technical information.

Ivan has both science and business background, he holds a degree and MSc in Physics from Universidad de Salamanca, and an MBA from IE Business School.  Ivan is very active in medical device industry, and he is part of the MedTech SPIN Steering Committee of TOPRA (The Organization of Professionals in Regulatory Affairs).

After having a chronic sports injury while playing basketball, andspending many years in rehabilitation, he decided after physics graduation towork in the medical devices industry. Ivan has lived in different countries andlikes travelling, painting, and adventure sports, and has special interest ininnovation, entrepreneurship, and technology. MedBoard is not the firstproject, and Ivan has have a number of entrepreneurship projects in the past,in the medical and outside of medical devices industry.

Before Medboard, Ivan had worked for many years as a consultant for medical companies in the areas of product and business development, regulations, and strategy, from operational roles to advising executives. He has broad experience with different types and classes of medical devices and combination products, supporting a variety of organization models, from start-ups to large corporations. 

Ivan Perez Chamorro – CEO and Founder MedboardCoupon Code

Ivan told me that he wanted to make an offer to you. Anyone of you that is subscribing to Medboard for 1 year will receive 1 month free with the Coupon Code EASYMEDICAL.

So don’t hesitate to use it or to share that with your colleagues if they need the support of this solution.

Anyway, you still have the possibility to make a free trial at the beginning to test it. So go to www.medboardco.com

Reference

Ivan-Perez Chamorro LINKEDIN:
linkedin.com/in/ivan-perez-chamorro-804b0b22

Medboard website: www.medboardco.com

Medboard LinkedIn: https://www.linkedin.com/company/medboardco/

Coupon Code: EASYMEDICAL

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

Link of the Video: https://youtu.be/8VlYimKsrjI

The post Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro 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.

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.

Are you struggling because issues are popping-up and you have no time to solve everything. This creates stress and you have no time to think and put in place a strategy?

I want to help you to move from Correction to Prevention. Because the only way for you to come back to a normal situation is to prevent those issues to arrive to your desk. How can we do that?

On this episode of the Medical Device made Easy Podcast, I will show you a method that you can use which is bringing a lot of value. I use the acronym ODIAC to describe it.

• Observation
• Discovery
• Idea
• Action
• Confirmation

I will go with you through all those steps and below, I provide you a link with a Free Template to download. This is the kind of template that you can use to follow the methodology on the field.

This method is not only for Medical Devices but for all businesses that want to move from Correction to Prevention. Let’s share that with them.

Let me know on the comments if you think this is something that you can use. Or maybe you have another method to suggest. Don’t hesitate to write to me.

Resource

• Free ODIAC Template: https://mailchi.mp/4848d29996e2/odiac
• Learn about ISO 13485.2016 Quality Management System: https://easymedicaldevice.com/faq-iso-13485/

Follow Me

• Linkedin: https://easymedicaldevice.com/linkedin
• Facebook group: https://easymedicaldevice.com/facebookgroup
• Blog: Https://easymedicaldevice.com

Podcast AudioEpisode 8 – From Correction to Prevention with ODIAC

Check on the menu all the places where this podcast is available. I hope you’ll enjoy it.

Youtube Video

https://www.youtube.com/embed/6UJB4ecmb3A?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Don’t forget to subscribe to the YouTube Channel and activate the bell to see all my new videos on Medical Device Regulation and Standards.

http://www.youtube.com/c/EasyMedicalDevice

The post Episode 8 – From Correction to Prevention with ODIAC 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.