Easy Medical Device Podcast

Podcast Episode 18 – https://podcast.easymedicaldevice.com/18Podcast Episode 18 – Medical Device situation with Petra Ognjenovic

Since we have all those transition happening in the European Medical Device regulations, I wanted to understand the situation on the recruitment market. I contacted Petra Ognjenovic from SciPro Global to help us have a better view.

She is leading the lifescience department of the DACH region which are the acronyms of Deutschland (Germany), Austria and Switzerland (Confederation Helvetique).

We will talk mainly about the European Union situation for the Quality and Regulatory affairs people. She really provided great information as I was also no aware of the situation.

About Petra Ognjenovic

Hello, I amPetra Ognjenovic, a Life Sciences recruitment specialist.

I was born inthe Netherlands, my parents are both Croatian and I grew up in Munich, Germany.

I studied twoMasters Degrees in Human Resources Education & Management and Philosophy,Psychology & Economics; Following my graduation, I was approached by SciPro,a leading recruitment business in the Life Sciences industry, and offered theopportunity to be responsible for the DACH Region within medical devices.

I think thatwe have a huge responsibility within our industry and I am very happy that Ihave joined an international recruitment company full of very talented andpassionate people, who, through our global network, are able to find the besttalent in the market for our customers.

We arefundamentally, a people business and we love to give back to our communities.This year, we have partnered with Designability, a medical devices charityorganisation. Designability create innovative medical devices to help peopleliving with disabilities to have a better quality of life. This year, SciProwill be raising money to fund our own ‘Wizzybug’ a mobility device designed fordisabled children under 5. For further information please follow this Link: https://www.sciproglobal.com/csr

One thing is for sure, I love my job and I love my industry so I am happy to be here today to share some insights, from the perspective of a recruitment consultant, within the Medical Devices Industry, during the MDR transition period.

Related links

• Petra Linkedin Profile: https://www.linkedin.com/in/petra-ognjenovic
• SciPro Global: http://www.sciproglobal.com
• Episode 10 – Qunique with Angelina Hakim: https://podcast.easymedicaldevice.com/10
• Video – Quality cost too much: https://easymedicaldevice.com/quality_cost_too_much
• Article Human resources and the Resource Based View of the Firm: https://digitalcommons.ilr.cornell.edu/cgi/viewcontent.cgi?article=1065&context=cahrswp

https://www.youtube.com/embed/qTVyY_7qMeY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 18 – QA RA Recruitment situation with Petra Ognjenovic 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.

Episode 17 – How to prepare for an unannounced audit with Florent GuyonAudio Podcast – Unannounced audit stories with Florent Guyon

Do you want to know how to prepare for an unannounced audit? Florent Guyon starts to be an expert on that. Within 5 months in 2017, he received 5 Unannounced audits when he was working at Statice Innovation. It was crazy. He decided to make a Video to make fun of the situation and this was really hilarious (It is in French but can be automatically translated in English).

During this episode we will talk about:

• Unannounced audits
• The Biomedical Engineering School ISIFC
• The Event “La rentrée du DM”

All the links are at the bottom.

Florent has more than 25 years of experience in the Medical Device field. He recently joined Nexialist as business developer but he still remains associate professor at the Biomedical Engineering School ISIFC.

Links

■ Nexialist: http://www.nexialist.fr/en/home/
■ Florent Guyon Linkedin: https://www.linkedin.com/in/florent-guyon/
■ Florent Video on Unannounced audits:https://youtu.be/ABa-slB2qWE
■ ISIFC Biomedical Engineering School: http://isifc.univ-fcomte.fr/pages/en/index.html
■ Event “La rentrée du DM”: https://www.larentreedudm.com/
■ Once Upon a time in America: https://www.imdb.com/title/tt0087843/

https://www.youtube.com/embed/779T5UUKmuQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Youtube Video of the Interview with Florent Guyon from Nexialist

The post Episode 17 – Unannounced audit stories with Florent Guyon 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 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.

Episode 16 – From Disease to Medical Device with Sean Hamilton

Sean Hamilton from War on Epilepsy is sharing with us its story and why his condition helped him to become an entrepreneur and create a medical devices company.

Sean is epileptic and he developed a device specifically for people with the same condition. This story is really powerful. Instead of just trying to live his life only, he is now trying to impact other peoples lives.

Sean is in the UK, so the Brexit can impact his project and we’ll talk about the compliance part of his project. Apparently, he already anticipated a lot of the issues and works with experts to be up-to-date.

About Sean Hamilton

My life has been a Rollercoaster from, at just 18 providing IT Support in a serviced desk space which resulted in experiencing the ups and downs of business as well as success and failure.
To even before that, with a Lifelong dream that I still have to this day of being a Paramedic, sadly due to many health challenges that was not & Is not possible, but my passion for helping people, Health, Medicine & Technology has not wavered.

My journey so far Includes the Peter Jones’ National Enterprise Academy in Amersham then onto to pitch at “Prysm Group’s Business show Midas Touch back in November 2010, was their youngest ever pitcher at just 19 having received praise & many offers of support from an incredible panel made up of the one and only Chelsey Baker an incredible serial entrepreneur, mentor, Model, Presenter, host and columnist, Rachel Elnaugh the founder of Red Letter days, Roy Seaman of Franchise Development services Last but by absolutely no means least Jonathan Pfahl MD and founder of the UK’s No1 Mentoring and Private funding organisation: Rockstar Group whom i took up the offer to join forces with & thus Rockstar Youth was born, The Experience working alongside Jonathan Is one I would not trade for the world!

Entrepreneurship is a lifelong journey full of twists & turns and different paths it has challenges certainly & rewards undoubtedly, It’s what you do with both that determines the person you will be.

Age & qualifications should not determine how experienced you are or how Succesful you are going to be, experience & success come by doing!
you win some, you lose some, Life isn’t just about the successes it’s as much about the failures. practice really does make perfect & don’t ever be afraid to ask for help.

I am a strong believer in “callaboration as a pose to competition, afterall working together we can achieve more”
You can’t do it alone & there is No “I” in team!

Certainly don’t be afraid to take that leap because Life isn’t about what if…

Book recommended by Sean Hamilton

LINK

Links

• Sean LinkedIn Profile:
  linkedin.com/in/sean-hamilton-27029529
• Twitter: @seanpreneur
• War On Epilepsy website: https://waronepilepsy.com
• Book “Patient as CEO”: https://amzn.to/2Yi43Lv

https://www.youtube.com/embed/pf0I1snnJgs?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 16 – From Disease to a Medical Device with Sean Hamilton 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.

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.

Podcast Episode 15 – MDR & IVDR discussion with Erik Vollebregt – Part 2

On this new episode, we continue to discuss with Erik Vollebregt on the MDR and IVDR. This is the second part.

If you missed part 1, you should go to:
► https://podcast.easymedicaldevice.com/14/ https://podcast.easymedicaldevice.com/14/

On this part Erik is answering my questions on:

• New regulation for Small and Big companies
• Notified bodies reduction
• Brexit and consequences for Notified Bodies
• and also rule 11 for classification of software

Biography

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 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.”

References

• Erik’s Linkedin Profile: https://www.linkedin.com/in/erikvollebregt
• Erik’s Twitter: https://twitter.com/MedDevLegal
• Medical Devices Legal Blog: https://medicaldeviceslegal.com/
• AXON Lawyer: https://www.axonlawyers.com
• PART 1: https://podcast.easymedicaldevice.com/14/

https://www.youtube.com/embed/nL0928StIi0?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Youtube Video – MDR & IVDR discussion with Erik Vollebregt – Part 2

The post Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2 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 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.

Episode 14 – MDR & IVDR explanation with Erik VollebregtEpisode 14 – EU MDR and IVDR explanation with Erik Vollebregt

On this 2 part episode, Erik Vollebregt will open our eyes about the EU MDR 2017/745 and EU IVDR 2017/746.

On his blog, MedicalDeviceslegal.com, he share openly his opinion about Medical Device Regulations. As he is a lawyer at AXON Lawyer firm, he has this ability to tell us stories like if this was a speach done in a justice court.

I asked him all the questions about EU MDR and IVDR and also about Brexit which we will see more on Part 2.

Biography

Erik specialises 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 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 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

Erik’s Linkedin Profile: https://www.linkedin.com/in/erikvollebregt
Erik’s Twitter: https://twitter.com/MedDevLegal
Medical Devices Legal Blog: https://medicaldeviceslegal.com/
AXON Lawyer: https://www.axonlawyers.com

https://www.youtube.com/embed/xk_Rm9s2V_A?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1) 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.

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.

Episode 13 of the Medical Device made Easy Podcast – Brexit Talk

We are around 1 month before the BREXIT planned on March 29th, 2019 and I asked Richard Young, Technical Director at Sensus Group located in the UK to talk to us about this situation.

Richard will provide to the Medical Device Industry affected by the Brexit situation some pieces of advice. What would they do in case they have done nothing due to Brexit? Which Notified Body to select? Will there be any disruption of products?

He answered all my questions and you can feel it’s really difficult for him also as there are so many unknowns.

Biography

Richard had more than 25 years’ experience in senior Quality Assurance and Regulatory Affairs roles in a diverse range of Medical Device and In Vitro Diagnostic (IVD) companies.

Having traveled the world honing his expertise and gaining an extensive range of industry contacts, Richard now feels he can independently offer a truly innovative range of services – all designed with you in mind.  His goal is to provide you with exactly what you need, quickly and effectively.

Links

• Richard Young LinkedIn: linkedin.com/in/richardmjyoung
• Sensus Group: www.sensus-group.com
• UK Draft legislation: https://www.legislation.gov.uk/ukdsi/2019/9780111179260/contents
• European Commission (Brexit): https://ec.europa.eu/commission/brexit-negotiations_en
• BSI certificate transfer: https://www.bsigroup.com/en-GB/medical-devices/our-services/transfer-to-bsi/

https://www.youtube.com/embed/BY8gZdZUvcs?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 13 – Brexit Talk with Richard Young 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.