A top podcast for healthcare leaders, with over one million downloads, Radio Advisory is your weekly download on how to untangle the industry's most pressing challenges to help leaders like you make the best business decisions for your organization. From unpacking major trends in care delivery—like site-of-care shifts and the rise of high-cost drugs—to demystifying stakeholder dynamics, to shining a spotlight on priorities that may get overlooked, we're here to help. Our hosts and seasoned r ...
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continue reading
Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
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Is FMEA bad for your Risk Management?
Manage episode 450091202 series 2591977
Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree.
Who is Rod Beuzeval?
Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance, clinical evaluation, risk management, project management, and remediation activities. Rod has worked for a notified body, conducted audits against EN ISO 13485, and supported reviews of technical documentation for medical device manufacturers in Europe. His experience includes Class I, II, and III devices, software as a medical device, drug delivery devices, IVDs, and active implantable medical devices.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link
- Leap Compliance LinkedIn: www.linkedin.com/company/leap-compliance
- Leap Compliance website: www.leapcompliance.com
- ISO 14971 Standard: https://www.evs.ee/en/evs-en-iso-14971-2019
- Video: What is ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U
- Podcast: Why Risk Management is important for Medical Devices: https://podcast.easymedicaldevice.com/207-2/
- eQMS for Risk Management: https://eqms-smarteye.com/
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 Is FMEA bad for your Risk Management? appeared first on Medical Device made Easy Podcast. hamza benafqir
328 episoder
Del
Manage episode 450091202 series 2591977
Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree.
Who is Rod Beuzeval?
Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance, clinical evaluation, risk management, project management, and remediation activities. Rod has worked for a notified body, conducted audits against EN ISO 13485, and supported reviews of technical documentation for medical device manufacturers in Europe. His experience includes Class I, II, and III devices, software as a medical device, drug delivery devices, IVDs, and active implantable medical devices.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link
- Leap Compliance LinkedIn: www.linkedin.com/company/leap-compliance
- Leap Compliance website: www.leapcompliance.com
- ISO 14971 Standard: https://www.evs.ee/en/evs-en-iso-14971-2019
- Video: What is ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U
- Podcast: Why Risk Management is important for Medical Devices: https://podcast.easymedicaldevice.com/207-2/
- eQMS for Risk Management: https://eqms-smarteye.com/
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 Is FMEA bad for your Risk Management? appeared first on Medical Device made Easy Podcast. hamza benafqir
328 episoder
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Lik Medical Device made Easy Podcast
A top podcast for healthcare leaders, with over one million downloads, Radio Advisory is your weekly download on how to untangle the industry's most pressing challenges to help leaders like you make the best business decisions for your organization. From unpacking major trends in care delivery—like site-of-care shifts and the rise of high-cost drugs—to demystifying stakeholder dynamics, to shining a spotlight on priorities that may get overlooked, we're here to help. Our hosts and seasoned r ...
…
continue reading
How can business help solve society’s biggest challenges? Welcome to Series 3 of Take on Tomorrow, the award-winning podcast from PwC that examines the biggest problems facing society and the role business can—and should—play in solving them. This series, we’re welcoming broadcaster and journalist Femi Oke to the show. She joins podcaster and journalist Lizzie O’Leary, and together with industry innovators, tech trailblazers and visionary leaders from around the globe, they’ll explore timely ...
…
continue reading
Alessandro Bogliari, CEO and Co-Founder of The Influencer Marketing Factory, a global influencer marketing agency, talks with great guests about influencer marketing, social media, the creator economy, social commerce and much more.
…
continue reading
1
The Brutal Truth about Sales and Selling - We interview the world's best B2B Enterprise salespeople.
Brian Burns
No BS Allowed - Are you sick of empty suits telling you to work harder? - Learn about The Maverick Selling Method, which models the world's best salespeople and what they do differently. If you are in sales and are passionate about selling, you will like this podcast. The focus is on b2b sales and selling. If you are selling or in sales, this podcast is for you. I cover cold calling, spin selling, challenger sale, solution selling, and advanced selling skills. Strategic selling, LinkedIn, sa ...
…
continue reading
Join host and Harvard Business School Online Creative Director Chris Linnane as he sits down with HBS faculty to discuss business education in a way that’s both entertaining and insightful. The Parlor Room is your key to breaking down academic theory without sacrificing depth—all while gaining practical takeaways for navigating the business world.
…
continue reading
Introducing The Unshakeables, a new podcast from Chase for Business and iHeartMedia's Ruby Studio. Small businesses are the heart and soul of this country, but it takes a brave individual to start and run a company of their own. From mom-and-pop coffee shops to auto-detailing garages -- no matter the type of industry you’re in, every small business owner knows that the journey is full of the unexpected. A single moment may even change the course of your business forever. Those who stand firm ...
…
continue reading
Best Business Podcast (Gold), British Podcast Awards 2023 How do you build a fully electric motorcycle with no compromises on performance? How can we truly experience what the virtual world feels like? What does it take to design the first commercially available flying car? And how do you build a lightsaber? These are some of the questions this podcast answers as we share the moments where digital transforms physical, and meet the brilliant minds behind some of the most innovative products a ...
…
continue reading
Custom Manufacturing Industry podcast is an entrepreneurship and motivational podcast on all platforms, hosted by Aaron Clippinger. Being CEO of multiple companies including the signage industry and the software industry, Aaron has over 20 years of consulting and business management. His software has grown internationally and with over a billion dollars annually going through the software. Using his Accounting degree, Aaron will be talking about his organizational ways to get things done. Hi ...
…
continue reading
The best sales leaders in the world are revealing their points of view, playbooks, and tried and true tactics...only on Reveal: The Revenue AI Podcast by Gong. Join us each month as host Dana Feldman digs deep into the world of the sales leaders she admires and aspires to be from some of the largest and most prominent organizations. Whether you're a CRO or aspiring to be one, these conversations will help you lead teams well, surpass revenue goals, and stay ahead of industry trends. Dana Fel ...
…
continue reading
Kipp Bodnar (HubSpot’s CMO) and Kieran Flanagan (Zapier’s CMO), lead you down the rabbit hole of marketing trends, growth tactics and innovation. On the way you’ll pick up undiscovered strategies to give you that slight edge for success. These are not your typical twitter thread regurgitated marketing tactics that everyone is doing. These are new methods, with unfiltered examination of successful fresh ideas.
…
continue reading
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