Ready to move into the MDR space?

This podcast is for you, if you’re facing challenges within all stages of getting a product to market. To help you we’ve gathered some of the greatest and most influential minds in the Medical Device industry, to get their insights on how to go from an idea to a market success.

You’ll be accompanied by our host, Helene Quie, the founder and CEO of Qmed Consulting.

- or find us here
The Qmed Podcast

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Conducting Clinical Studies at Hospitals

Season: 2
Episode: 13
4 weeks ago
25:14

In this episode, Helene Quie discusses the topic “Conducting Clinical Studies at Hospitals” with study nurse, Christina Møller.

With: Christina Møller, Helene Quie

Submissions in Norway

Season: 2
Episode: 12
2 months ago
13:29

In this episode, Helene Quie discusses the topic “Submissions in Norway” with Qmed’s
Clinical Specialists in Submission Processes. Learn about the country’s special requirements, where you can the necessary documentation, and relevant tips and tricks for a successful submission process.

With: Helene Quie

Submissions in Denmark

Season: 2
Episode: 11
3 months ago
18:09

In this episode we discuss submissions in Denmark with Clinical Specialist, Christina Duun Nielsen

With: Christina Duun Nielsen
#clinicalresearch, #healthcare, #medical, #medtech, #submissions

Market Access with Søren Underbjerg

Season: 2
Episode: 10
8 months ago
24:08

In this episode, we are joined by Qmed’s market access expert Søren Underbjerg, to discuss the key elements for developing market access strategies.

With: Helene Quie, Søren Underbjerg
#access, #device, #market, #medical, #qmed

An Update on EudaMed w. Richard Houlihan

Season: 2
Episode: 9
12 months ago
35:24

In this episode, we are joined by Kami Faust from Norway Health Tech, to discuss what action all medical device manufacturers should take right now to prepare for the upcoming changes.

With: Richard Houlihan
#eudamed, #qmed

How to prepare for the upcoming changes with Norway Health Tech

Season: 2
Episode: 8
1 year ago
15:00

In this episode, we are joined by Kami Faust from Norway Health Tech, to discuss what action all medical device manufacturers should take right now to prepare for the upcoming changes.

With: Helene Quie
#consulting, #faust, #health, #helene, #kami, #norway, #qmed, #quie, #tech

With Lasse Staal from AddiFab

Season: 2
Episode: 7
1 year ago
49:49

In this episode we are joined by Lasse Staal, CEO of Danish 3D-Printing Pioneer, AddiFab, to talk about 3D-printing of medical devices.

With: Lasse Staal

With Ernesto Nogueira from ValueConnected

Season: 2
Episode: 6
1 year ago
40:56

In this episode of The Qmed Podcast we’re joined by Ernesto Nogueira, to talk about Artificial intelligence in the medical device industry.

With: Ernesto Nogueira

With Rasmus Lou-Moeller from Meggitt Denmark

Season: 2
Episode: 5
1 year ago
20:58

The RoHS directive is coming! Had the pleasure of talking to Rasmus Lou-Moeller, head of R&D at Meggitt Denmark, about the RoHS directive and how it will affect the medical device industry. Through our conversation, Rasmus explained the pros and cons of the directive and gave advice to medical device manufacturers who are currently using piezoceramics in their products.

With: Rasmus Lou-Moeller
#helenequie, #meggitt, #qmed, #qmedconsulting, #rohs

With Monir El Azzouzi from Easy Medical Device

Season: 2
Episode: 4
1 year ago
52:42

Clinical evaluation and the equivalence pathway! Are you in doubt if it is still possible to use the equivalence pathway under MDR? Are there different requirement for different classes of products? How to show equivalence under MDR. Hear practical examples based on feedback from the Notified Bodies.

With: Monir El Azzouzi

With David Rutledge from Global Strategic Solutions

Season: 2
Episode: 3
2 years ago
61:59

Had the absolute pleasure of talking to David Rutledge about something I myself find a very difficult assessment process; Benefit – Risk Assessment.

The Benefit – Risk Assessment is mentioned 28 times during the MDR and os one of the core processes especially in the clinical evidence process.

Through our conversation David made the process very tangible and I would clearly recommend listening to our conversation.

With: David Rutledge

With Victor Staalkjaer and Andreas Tuxen from June Systems

Season: 2
Episode: 2
2 years ago
28:36

Starting a company within the regulatory field of medical devices contains a long series of restrictions, which at times can seem challenging.

In our 2 Episode of our Qmed Consulting Podcast (Season 2), we get an insight of Victor and Andreas, experience within the Quality Management System.

The two engineers have developed a Class IIa medical device. The device measures the amount of oxygen within a child under labor. It prevents unnecessary C-sections, and any complications of birth there may occur.

The Qmed Podcast gives an understanding of how to navigate in an early start-up phase of EQMS.

With: Andreas Tuxen, Victor Staalkjaer
Neurescue

With Bjørn Broby from Neurescue

Season: 2
Episode: 1
2 years ago
34:40

One of the most common challenges within start-up companies is how to get off the ground and get appropriately funded.
Questions regarding budgeting, pick of the investor, deciding the worth of one’s company, and many more.

We have, therefore, in the first episode, of our new second season, invited Bjørn Broby from @Nerescue to give start-up companies a broader understanding of how to navigate in the funding process. We hope you will enjoy listening in and tap in on Bjørn’s vast amount of experience.

With: Bjørn Broby
Neurescue

The Qmed Podcast #10 with Helene Quie

Season: 1
Episode: 10
3 years ago
86:35
In this final episode of our first season, Helene looks back at great interviews we’ve had and share some of her favourite conversations and takeaways. This is a great episode for those who are new to the podcast, but also for our avid listeners to make sure they haven’t miss the important points from our talented guests. Have a great summer – See you in the fall!
With: Helene Quie
#helene, #qmed, #quie

The Qmed Podcast #9 with Heidi M. Mehrzad

Season: 1
Episode: 9
3 years ago
28:18
Human factors and usability are terms often used interchangeably. Yes, it can be a tricky topic, and one that can create some confusion. Therefore, in this episode, I’ve invited Heidi Mehrzad from HFUX Research to guide us on the difficult topic. Hope you will enjoy listening in and tap in on Heidi’s vast amount of experience.

 

With: Heidi M. Mehrzad

The Qmed Podcast #8 with Richard Houlihan

Season: 1
Episode: 8
3 years ago
28:18

In this episode of The Qmed Podcast we’ll be joined by Richard Houlihan, to talk about “The EUDAMED database and the basic fundament behind”. Being part of the European Commission MDR Eudamed technical management position Richard can provide a unique prospective on Eudamed’s inner workings and design bring a better understanding of the Eudamed technical challenges facing companies.

With: Charlotte Piester
#eudamed, #qmed

The Qmed Podcast #7 with Charlotte Piester

Season: 1
Episode: 7
3 years ago
21:49

In this episode we are joined by Charlotte Piester from Sinua Partners and discuss how to use clinical and regulatory requirements as commercial competitive advantages within the MedTech industry, completely aligned with the changes to the MDR and the need for companies to carefully consider their claims, market access and which data to collect when – creating The Evidence Gap Plan.

With: Charlotte Piester
#device, #mdr, #medical, #qmed

The Qmed Podcast #6 with Ernesto Nogueira

Season: 1
Episode: 6
3 years ago
31:48

In this episode of The Qmed Podcast we’re joined by Ernesto Nogueira, to talk about key steps for SMEs to know about, regarding commercialisation when starting up the development of their innovative new medical device.

Ernesto has numerous years of experience within this field assessing and applying the value of medical technologies in commercial and market access projects.

He is sharing with us key questions to ask yourself early stage during the development process to ensure that you can successfully launch your idea when ready.

With: Ernesto Nogueira

The Qmed Podcast #5 with Dr. Bassil Akra

Season: 1
Episode: 5
3 years ago
48:07

In this episode we’re proud to welcome Dr. Bassil Akra. We are discussing the MDR – the new regulation and changes to come seen from the side of the Notified Body and touch on important topics such as Technical Documents, new reports such as SPUR and SSCP and use of clinical evidence from equivalent products for low risk class products.

With: Dr. Bassil Akra

The Qmed Podcast #4 with Sandra Ferretti

Season: 1
Episode: 4
3 years ago
42:53

In this episode we’re joined by Sandra Ferretti from the Obelis Group and Authorised Representative out of Brussels and we are discussing the EUDAMED database and the role of the Authorised Representative under the MDR.

With: Sandra Ferretti
#device, #eudamed, #mdr, #medical, #qmed

The Qmed Podcast #3 with Gert Andersen

Season: 1
Episode: 3
3 years ago
49:46
With: Gert Andersen

The Qmed Podcast #2 with Semih Oktay

Season: 1
Episode: 2
3 years ago
74:59

In this episode we’re guested by Semih Oktay, President and founder of CardioMed Device Consultants. We touch upon getting an overview of FDA structure and organisation and changes to come by June 2019, Risk classification, FDA approval processes and more.

With: Semih Oktay

The Qmed Podcast #1 with Hilde Viroux

Season: 1
Episode: 1
3 years ago
70:38

In the first episode of The Qmed Podcast we’re joined by Hilde Viroux from HCL Technologies, to talk about MDR conversion strategy, including maximum use of ‘grace period’, product prioritization, product rationalization and more.

With: Hilde Viroux
#device, #health, #medical, #qmed