Easy Medical Device Podcast

Be the best candidate ever. If you are working on the Medical Device space, you are maybe looking for a new opportunity or a promotion within your company. To help you made the move on the best conditions, I invited Mitch Robbins from The Anthony Michael Group who is specialized in the recruitment of Medical Device employees.

On this episode, we will help you to understand:

• The candidate value proposition
• Tips on how to be considered the best candidate
• How to get promoted within your company

For that, we will discuss specifically Quality and Regulatory Affairs skills. Because there are some criteria that you should consider when writing your profile on Linkedin or on your Resume. And I mentioned that for me Keywords is also an important part to sort the different CVs.

We will also talk about Mitch’s podcast which is helping you to improve yourself on this space by providing you some advice.

By the way, Mitch is the founder of the company but the company is called The Anthony Michael Group. Why? You´ll hear this great story as I will ask him this question.

Who is Mitch Robbins?

Mitch Robbins is the Founder and Managing Director of The Anthony Michael Group in a suburb of Denver, CO. Mitch and his team at AMG helps organizations (Med-Device, Diagnostics, and Digital Health) to hire the top 15% of Elite Technical Talent in areas like Regulatory Affairs, Quality, Engineering, R&D, Manufacturing and Operations. Mitch, himself, is consistently ranked across the world within the top 1% of Headhunters and has been the choice of the experts to deliver training to both rookies and seasoned recruiters across multiple disciplines on numerous occasions.

Links

• Mitch´s Linkedin Profile: https://www.linkedin.com/in/mitchrobbins/
• The Anthony Michael Group: https://theanthonymichaelgroup.com
• Mitch’s email: [email protected]
• The vault: https://theanthonymichaelgroup.com/elitecareervault
• RA/QA Today Podcast: https://podcasts.apple.com/us/podcast/ra-qa-today/id1374916087

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

The post Episode 38 – Be the Best Candidate Ever with Mitch Robbins 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.

How can you be considered the best candidate ever? This is what will be presented today by Mitch Robbins from the Anthony Michael Group. And learn also why he called his company with this name. The post Episode 38 – Be the Best Candidate Ever with Mitch Robbins appeared first on Medical Device made Easy Podcast.

If you have some difficulty to understand the concept of Usability and Human Factor, this episode is perfect for you. We will not specifically talk about theory but really about practice with a case study.

Sharon Ayd, CEO of Ayd Biopharma Consulting Group will be our guide. She will present to us a project where she was involved and where usability and human factor was key for its success.

Usability Study and Human Factor are really used a lot in the US, but now this is more and more demanded by regulators in Europe.

Who is Sharon Ayd?

Accomplished life science executive, with 30 yrs global experience in pharma/biotech & combination product/device industries. Founding member/C-level of three startups. Skilled in leading multi-national R&D drug development initiatives for complex biotechnology, pharmaceutical and combination products in large organizations & manufacturing environments. Expert knowledge in US FDA regulations. Have been responsible for ~100 drug approvals.

Links

• Sharon Linkedin: https://www.linkedin.com/in/sharonayd/
• Ayd Biopharma Consulting Group: https://www.aydbiopharmaconsultinggroup.com/

https://www.youtube.com/embed/6mPrW51DcXk?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 37 – Usability & Human Factor with Sharon Ayd 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.

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.

You will hear the acronym PRRC more and more as with the new Medical Device Regulation MDR 2017/745 and IVDR 2017/746 it is mandatory to have one at your company.

But what does it mean? This means Person Responsible for Regulatory Compliance. It will be a key person on your organization and you cannot appoint anybody at this role.

To help you understand what are the requirements, Erik Vollebregt from Axon Lawyers and myself will review with you the last guidance issued by MDCG. There is some clarification but there is still some unknown.

So, if you want to be compliant with the MDR, you need to listen to that.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation.

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017 about Erik:

He is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Links

• MDCG guidance 2019-7 : https://tinyurl.com/MDR-PRRC
• Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt
• Axon Lawyers : https://www.axonlawyers.com/author/erikvollebregt/
• Erik Vollebregt Twitter: https://twitter.com/MedDevLegal
• Video Role of a PRRC: https://youtu.be/aCJ7x-KfOro

https://www.youtube.com/embed/e8xT1hAR0ao?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 36 – How to choose your PRRC with Erik Vollebregt 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.

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.

If you haven’t jumped on the Digitalization train, I advise you to listen to this episode, because our mission will be to convince you to scrap your papers and start to use software.

This can save you time and avoid some bad situation with the management of your documents. I will tell you a story at the beginning of the episode and if you are in this situation, then you should think of Digitalization of your QA RA documents.

To help us on this journey, I have invited Michael Kania from Meddevo.com. He will explain to use the advantage of Digitalization and also present his solution that is dedicated to some regulations as MDR or IVDR.

Who is Michael Kania?

” The medical device regulation is without question a big challenge for every manufacturer. At the same time, there is a shortage of professionals. I would like to show you how digitalization can help your company reduce costs, increase compliance and master MDR. ” by Michael Kania

Links from the episode

• Linkedin Michael Kania: https://www.linkedin.com/in/michaelmkania/
• Meddevo: https://meddevo.com

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

The post Episode 35 – Digitalization of QA RA with Michael Kania 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.

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.

With the new technologies as the Apple Watch, Fitbit or other application, we can now collect more data or more Real World Data.

This will be the topic of today´s podcast. Alethea Wieland from Clinical Research Strategies will help us understand the concept of Real World Data for Medical Devices.

• What can we do with this information?
• What are the parameters we should consider?
• Can we show them to Regulators to confirm our products are safe?

We will try to answer all those questions.

Who is Alethea Wieland?

Alethea Wieland is Founder and President of Clinical Research Strategies, LLC, an executive-level management consulting firm and contract research organization for the life science industry established in 2011.

Her focus is on offering agile, flexible staffing models for clinical trial resourcing; training and managing resilient, high-performing clinical operations teams using human-centered design techniques; and, mitigating risks of clinical trials by facilitating the best Sponsor-CRO partnerships who practice accountability, compliance, and transparency.

She is an advocate of strong contractual arrangements, and frequently meeting with regulators and numerous stakeholders which results in a win-win mindset. Learn more by connecting with her on LinkedIn, and by visiting her website at www.clinicalresearchstrategies.com.

Links

► Clinical Research Strategies: https://www.clinicalresearchstrategies.com
► Alethea Wieland Linkedin: https://www.linkedin.com/in/alethea
► Alethea Wieland Twitter: https://twitter.com/alethea_wieland

https://www.youtube.com/embed/nT-KBkvu5yg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 34 – Real-World Data for Medical Devices with Alethea Wieland 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.

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.