Angelina Hakim's guest appearances

Angelina Hakim

Medical Device made Easy Podcast

Project Medtech Podcast

Mitch Robbins

Jon Bergsteinsson

Michelle Lott

Jon Speer

Michael Moore

Jason Lim

Erik Vollebregt

Tania Aprigliano

Ed Drower

Justin Bushko

Natasha Bankowski

Helene Quie

Sharon Ayd

Karandeep Badwal

Samantha Alsbury

OwlTail

In this episode, Angelina and I discuss her incredible journey, quality management systems, MDR, and more.    Angelina Hakim Bio: Angelina Hakim is the founder, Co-Owner and CEO of QUNIQUE GmbH. She developed her experience through the different stations of her career at global medical devices manufacturers as well as consulting organizations. At Olympus Winter &amp; Ibe, Institut Straumann and Schiller AG she was exposed to medical devices from classes I to III and was responsible for documenting and establishing procedures, work instructions and compiling the technical documentation in compliance with applicable international standards and regulations. Thanks to her detailed knowledge of MDR 2017/745, IVDR 2017/746, Medical Devices Single Audit Program (MDSAP) and ISO 13485 requirements, Angelina is able to combine her past experience with the new requirements to train and support many customers around the world to adapt their quality systems and update their product technical documentation.

In this episode, Angelina and I discuss her incredible journey, quality management systems, MDR, and more.    Angelina Hakim Bio: Angelina Hakim is the founder, Co-Owner and CEO of QUNIQUE GmbH. She developed her experience through the different stations of her career at global medical devices manufacturers as well as consulting organizations. At Olympus Winter &amp; Ibe, Institut Straumann and Schiller AG she was exposed to medical devices from classes I to III and was responsible for documenting and establishing procedures, work instructions and compiling the technical documentation in compliance with applicable international standards and regulations. Thanks to her detailed knowledge of MDR 2017/745, IVDR 2017/746, Medical Devices Single Audit Program (MDSAP) and ISO 13485 requirements, Angelina is able to combine her past experience with the new requirements to train and support many customers around the world to adapt their quality systems and update their product technical documentation.

Episode 28 | Angelina Hakim, CEO and Co-Founder of Qunique GmbH | An Incredible Journey to becoming an Entrepreneur 

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. Infographic https://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      Video Podcast Episode    Resources 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 AuditsThe post Episode 10 – Understand MDSAP with Angelina Hakim first appeared on Medical Device made Easy Podcast.The post Episode 10 – Understand MDSAP with Angelina Hakim appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 <a href="https://easymedicaldevice.com/mdsap" rel="noreferrer noopener nofollow" target="_blank">my article</a> on my blog Easy Medical Device. <h2>Infographic</h2> <a href="https://easymedicaldevice.com/mdsap/" rel="nofollow" target="_blank">https://easymedicaldevice.com/mdsap/</a> <h2>Qunique</h2> 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. <h2>Video</h2> Video Podcast Episode <h2>Resources</h2> Qunique website: <a href="https://www.qunique.ch" rel="noreferrer noopener nofollow" target="_blank">https://www.qunique.ch</a> Angelina LinkedIn: <a href="https://www.linkedin.com/in/angelina-hakim-34b70225" rel="nofollow" target="_blank">linkedin.com/in/angelina-hakim-34b70225</a> Book recommendation Homo Deus: <a href="https://amzn.to/2UcomYl" rel="noreferrer noopener nofollow" target="_blank">https://amzn.to/2UcomYl</a><a href="https://amzn.to/2UcomYl" rel="nofollow" target="_blank">/</a> Easy Medical Device Article: <a href="https://easymedicaldevice.com/mdsap" rel="noreferrer noopener nofollow" target="_blank">https://easymedicaldevice.com/mdsap</a> <a href="https://podcast.easymedicaldevice.com/6/" rel="noreferrer noopener nofollow" target="_blank">Episode 6 – What are the 6 types of Medical Device Audits</a>The post <a href="https://podcast.easymedicaldevice.com/10/" rel="nofollow" target="_blank">Episode 10 – Understand MDSAP with Angelina Hakim</a> first appeared on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>.The post <a href="https://podcast.easymedicaldevice.com/10/" rel="nofollow" target="_blank">Episode 10 – Understand MDSAP with Angelina Hakim</a> appeared first on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>. <a href="https://podcast.easymedicaldevice.com/author/melazzouzi/" rel="nofollow" target="_blank">Monir El Azzouzi</a>

Episode 10 – Understand MDSAP with Angelina Hakim