Qserve Talks: Recent Episodes
Qserve Group
Qserve is your MedTech partner for Regulatory Affairs, Quality Affairs and Clinical Trials. In our first series: MDR Deadline Countdown, we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR. Do you have any specific subjects you would like us to highlight? Send them over to faqfriday@qservegroup.com
Welcome to our first series: MDR IVDR Deadline Countdown, where we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR.
During this episode, we will talk about the artificial intelligence.
Today, Gert Bos invited Coenraad Davidsdochter. Coenraad is the Qserve’s Software Expert . With over 20 years of experience in software development of which over 10 years in setting-up, maintaining and improving Quality Management Systems (QMS).
Do you have any questions for one of our experts? Feel free to contact us at faqfriday@qservegroup.com and perhaps we will answer your question in one of our vlogs or podcasts!0
Welcome to our first series: MDR IVDR Deadline Countdown, where we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR.
During this episode, we will talk about the IVDR implementation.
Today, Gert Bos invited Sue Spencer. Sue leads Qserve’s IVD service. She has over 30 years’ of experience in the Medical Device and IVD industries including extensive notified body experience
Do you have any questions for one of our experts? Feel free to contact us at faqfriday@qservegroup.com and perhaps we will answer your question in one of our vlogs or podcasts!
Welcome to our first series: MDR Deadline Countdown, where we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR.
During this episode, we will talk about Biocompatibility and toxicity.
Today, Gert Bos invited Bianca Lutters Qserve’s Regulatory Affairs Expert .
Bianca has more than 15 years experience in the medical devices field, ten of which have been spent at two major Notified Bodies, DEKRA and BSI. In her time working for Notified Bodies, Bianca assessed many design dossiers and technical files. . The last five years Bianca spent as Director Regulatory and Quality in a start-up company with high-risk biodegradable cardiovascular products.
Do you have any questions for one of our experts? Feel free to contact us at faqfriday@qservegroup.com and perhaps we will answer your question in one of our vlogs or podcasts!
Welcome to our first series: MDR Deadline Countdown, where we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR.
During this episode, we will talk about availability of Notified bodies.
Today, Gert Bos invited Sabina Hoekstra.
Sabina was elected as one of the Chairs of the NB-MED. Sabina is appointed as Regulatory Strategy Principal in the Medical Health Services division of TÜV SÜD Product Service GmbH. Together they will discuss about availability of Notified bodies.
Do you have any questions for one of our experts? Feel free to contact us at faqfriday@qservegroup.com and perhaps we will answer your question in one of our vlogs or podcasts!
Welcome to our first series: MDR Deadline Countdown, where we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR.
During this special episode, we will talk about legal issues in regard to the MDR.
Today, Gert Bos invited no one less than Erik Vollebregt from Axon Lawyers.
Erik is specialized 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. Together they will discuss legal issues in regard to the MDR.
Do you have any questions for one of our experts? Feel free to contact us at faqfriday@qservegroup.com and perhaps we will answer your question in one of our vlogs or podcasts!
Welcome to our first series: MDR Deadline Countdown, where we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR.
During our second episode, we will talk about sufficient clinical data with a specific focus on legacy products.
Today, Gert Bos invited not one but two guest speakers! Our first guest-speaker is Qserve's CRO Lead Wiebe Postma. Before Qserve, he obtained his Ph.D. in molecular biology and worked at a large orthopedic manufacturer.
Also joining us is Qserve’s EU MDR Lead, Giovanni Di Rienzo. Before joining Qserve, he worked at two Major Notified Bodies TÜV Sud and BSI, as well as in the medical device industry.
Do you have any questions for one of our experts? Feel free to contact us at faqfriday@qservegroup.com and perhaps we will answer your question in one of our vlogs or podcasts!
Welcome to our first series: MDR Deadline Countdown, where we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR.
During our very first episode, we will give you an overview of what we learned so far from the MDR.
Gert Bos invited Qserve’s EU MDR Lead, Giovanni Di Rienzo. Before joining Qserve, he worked at two Major Notified Bodies TÜV Sud and BSI, as well as in the medical device industry.
Together, they will discuss topics such as Remote Audits, PMCF plans and Notified Body availability.
Do you have any further questions? Feel free to contact us at faqfriday@qservegroup.com and perhaps we will answer your question in one of our vlogs or podcasts!