MDR impact on MDSW: what has changed from MDD?
Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)? Or will affect the CE marking of your first or next medical device software?
Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)? Or will affect the CE marking of your first or next medical device software?
One of our previous blogposts discussed medical device industry trends and innovations.
Since then, more recent data on the number of patent applications from the European Patent Organisation’s (EPO) yearly research were made available. These can be used as a measure for innovation within the medical technology sector and other sectors.
At QbD, we care a lot about knowledge sharing and about giving young potentials all the opportunities they need to kick off their career in life sciences. That’s why we started the QbD Academy. This year, we welcomed 15 young graduates during our ‘QbD Academy Week’, and they had a blast! Read all about it below.
Artificial Intelligence is the IT word in Medical Devices nowadays when it comes to software development. Every medical device company wants to fling it!
Nowadays, digital healthcare is taking an increasingly important place in the medical world through medical software, image processing, diagnostic support, home monitoring, etc… but all software used in a medical environment is not necessarily subject to medical regulations. Even the definition/designation of Software as a Medical Device (SaMD) can vary from country to country.
Brexit impacts the medical device markets of Scotland, England, Wales and Northern Ireland. Learn more on the consequences for manufacturers that place medical devices on the UK market here.
In the field of regenerative medicine, advanced therapy medicinal products (ATMPs) represent the next generation of medicines. It is, however, not so straightforward to translate this new expertise into a GMP process. In this article, you’ll learn more about the challenges and crucial aspects.
Sports, competitiveness, team spirit, joy and social responsibility have always been an essential part of QbD and TRIUM’s DNA. So – to celebrate both our 10-year anniversaries – we came up with an exciting event combining all of these values: our 10Y International Sports Challenge!
For four weeks – from 14/06 until 11/07 – we put our best foot forwards to complete the challenge and had a blast. Read all about it below!
The “funny” thing about bringing medical devices to market is that you first must ask yourself… whether your product IS a medical device or not, as well as in which countries it is and in which countries it is not. If your product is classified as a medical device, then it might be subject to constraints. On the other hand, your product might be or be perceived as more valuable, more safe, more performant to customers. Most of the time, however, the choice is not up to manufacturers. All depends on the market(s) you want to reach. Definitions vary from country to country, as do regulations. In this blog post, we will help you answer that one important question by sharing a brief overview of important regulations, their similarities, and their differences.
Risk management, the key to medical device safety, involves much more than ticking the FMEA box. Jeroen Verhoeven, one of our specialists in the matter, explains why and guides you through the ISO14971 standard (application of risk management to medical devices).
Now that it seems like we’re finally taming the COVID beast, many companies are preparing to make the switch to ‘hybrid working’: combining working from home with going back to the office. This concept, however, is not as self-explanatory as you may think. How do we make sure our people work as comfortably at home as they did at the office? Which types of tasks are we going to perform at home and which ones at the office, with efficiency and well-being in mind? And which role does the office still have to play in all of this? At QbD, we’re going the extra mile to put the new way of working to everyone’s advantage. If you need some inspiration, just follow our lead.
ATMPs are, by nature, highly complex and innovative therapies. And well-designed clinical trials are key to producing effective and safe ATMPs – ultimately increasing patients’ health and speeding up market authorization. In this blogpost, Marie-Paule Gyselen from TRIUM Clinical Consulting (part of the QbD Group) guides you through the most important ATMP-specific clinical trial challenges.
Launching a medical device requires much preparation. As these devices are heavily regulated, a company has to meet many requirements in different phases of the development and manufacturing process. Which phases are there to consider and what are their characteristics? This blog digs deeper into the lifecycle of a medical device and requirements that must be met in those phases.
Not sure where to start when validating your computerized systems? Follow these 10 steps as a guideline.
In the smart factories that came with Industry 4.0, digital twins of manufacturing processes are key to improving process robustness, development lead times and ultimately reducing costs. In this blog Evan Claes and Tommy Heck from our partner Antleron explain how digital twins work and why they are so vital, especially to ATMP manufacturing.
In this blog post, we give more insights into the challenges a QP faces when dealing with ATMPs. We talk about sterility, out-of-specification handling, batch release, and EU import testing.
The sales price of cell and gene therapies is influenced by multiple factors like Cost of Goods (COG), regulatory requirements, target market (or commercial aspect), and the development just to name a few. In this blog post you will learn more about the GOC aspect: what is this cost comprised of and how can you reduce it?
UDI is a new system that assigns a unique barcode to each individual medical device. It will become mandatory when MDR and IVDR enter into force, so as a manufacturer, you need to make sure you’re UDI-ready in time.
During the QbD Corona World Games, our online international team building event, thirteen randomly selected teams defended their honor.
A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace the Medical Device Directive (MDD) in May 2021. The regulation has been written to assure better quality and improve the safety aspects for all medical devices that
One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by leveraging the latest technological advancements. It is undeniable that the future of medical technology looks exciting and, obviously, being innovative requires a lot of specific technological expertise
Do you want to distinguish starting materials used for ATMPs from those used for transplants or transfusions? This distinction is made based on how the starting materials are processed and/or used clinically. We’ve listed the steps to make such a distinction, with the help of a flowchart. Current ATMP workflows
Recently, we announced that Quality by Design and TRIUM Clinical Consulting have joined forces to create an end-to-end offering for the lifecycle of medical products and therapies. A giant leap forward in the growth, expansion and development of both companies. Are you curious as to why TRIUM is the ideal
Among the Advanced Therapy Medicinal Products (ATMPs), in the immunotherapy market, nowadays two acronyms catch the eye: CAR-T and TCR-T. The two techniques are based on the insertion of a specific receptor on the T-cells to enable them to detect and kill the tumor cells specifically. When the receptor is
It’s obvious that product quality and patient safety are a top priority in the pharmaceutical industry. The quality by design methodology is used to build quality into production processes. By a comprehensive understanding of and insight in products and processes, continuous improvement of products and processes is possible. But how
GxP Processes Without question, the impact of GxP processes such as product quality and patient health are at the top of the list when it comes to assessing the risks of a computer system. These are crucial in deciding whether to validate a computerized system. Therefore, experience and end user
What does an automation pyramid entail? An automation pyramid visualises the integrated layers of technology used in manufacturing or industry combined with the level of control. From the bottom, where the production runs on motors, machinery, actuators, sensors and so on, to the top where the process is managed. How
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Have you read our earlier blogposts about the The importance of a dedicated team and skilled project manager for technology transfers, the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Until now, academia and research-based companies have been the major source of successful ATMP (gene therapy and cell- or tissue-engineered product) developments. Based on their success, pharmaceutical companies are trying
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Checking your phone to see when you took your last medication? Your watch vibrating and telling you to lay down because you will have a seizure soon, while at the same time notifying your emergency contact with your exact location?
Have you read our earlier blogposts about the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Life sciences enterprises in for example the pharmaceutical, biotechnology and medical devices industry must validate computer systems that have an impact on the product and thus the patient safety. A computer system consists of more than just software and hardware; it includes procedures, processes, equipment, training and much more. In
On the 4th of May, it was the turn of Maaike Tuinsma (Pharmaceutical Consultant at QbD) to give the Biomedical Engineering students of the University of Liège a lecture. Topic of this week: FDA & Medical Devices.
In this blogpost, we will dive into these complexities a little bit more and provide you with some useful tips to minimise the complexity of your tech transfers.
Monday 27 April, the fourth QbD guest lecture was on the agenda for the Biomedical Engineering students of the University of Liège. This time the students were introduced to software as a medical device and validation & qualification by QbD’ers Bart Verlinden and Pieter Smits.
(This blog is part of a series. Want to read the first part? Check it out here) After the Easter holidays, QbD resumed its guest lectures for the biomedical engineering students at the University of Liège. This week, our experienced consultants Jeroen Verhoeven and Steven Vinckx introduced them to the
A technology transfer can take place between buildings on the same production site, between different production plants from the same company or even between different companies. It can involve the transfer of various aspects, such as information, expertise, processes and assets. Thorough understanding between the sending and receiving units is
This blogpost aims to provide useful information for parties involved in the development of face masks in the fight against the COVID-19 pandemic. It lists the impact of the recommendations from the European Commission [1] on the development and distribution of face masks. In general, two types of face masks
Innovation is key to the success of companies and is driving many industries. This is certainly true for the medical technology sector. According to yearly research by the European Patent Organization (EPO) on filings and applications per field of technology, 13.833 med tech patent applications were filed in 2019. Contrary
A hiring freeze during Corona? No way! Although the current crisis has created new and unexpected challenges, QbD is not the kind of company to let these get in the way. In order to keep getting things done for our clients, our HR department is going the extra mile to
As long as the COVID-19 measures are in place, the QbD recruitment team continues to work from home. But thanks to modern technology, and our ‘getting things done’ mentality, it’s business as usual at QbD! Wondering what a working day looks like for our recruiters Tim and Karen? 9.00 am:
Hi! My name is Frederick Tison. I’m 26 years old and this is my third year at QbD. I’m currently active as a raw material specialist for a client. Together with fellow QbD’er Tijs Van Den Berghe, I’m responsible for setting up specifications for the raw materials that are purchased
What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer ground-breaking new opportunities for the treatment of disease and injury. ATMPs can be classified into three main types: Gene
The next episode in the guest lecture program for the students Biomedical Engineering at the University of Liège was a new experience for both trainers and trainees. Some social distance had to be covered by means of a webinar and some high-end glass fiber internet cabling. From our Kot in
As you know, QbD is a very sporty and healthy organization. Since today is the start of homework and social distancing week 2, we obviously miss our weekly Bootcamp together. But thank god for technology! We were able to set up a Bootcamp via livestream in collaboration with our beloved
There we were, in the ‘quartier Polytech’, looking for the department ‘Aérospatiale & Mécanique’ at the university of Liège. We had gotten up way too early in the morning, but a small holiday feeling at 8 AM on Monday was our reward, as we crossed the language border – Liège
Advanced therapy medicinal products (ATMP) is the group of therapies in which we use cells, genes, engineered tissues and combinations of the above with medical devices as a medicinal product. A medicinal product can be described as: any substance or combination of substances presented as having properties for treating or
Advanced therapy medicinal products (ATMP) are cell and gene therapies that provide new opportunities for the treatment of a variety of diseases and injuries. Due to the specificity and novelty of the ATMP sector, the development of these therapies faces a unique set of challenges. Artificial intelligence (AI), a broad
Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)? Or will affect the CE marking of your first or next medical device software?
One of our previous blogposts discussed medical device industry trends and innovations.
Since then, more recent data on the number of patent applications from the European Patent Organisation’s (EPO) yearly research were made available. These can be used as a measure for innovation within the medical technology sector and other sectors.
At QbD, we care a lot about knowledge sharing and about giving young potentials all the opportunities they need to kick off their career in life sciences. That’s why we started the QbD Academy. This year, we welcomed 15 young graduates during our ‘QbD Academy Week’, and they had a blast! Read all about it below.
Artificial Intelligence is the IT word in Medical Devices nowadays when it comes to software development. Every medical device company wants to fling it!
Nowadays, digital healthcare is taking an increasingly important place in the medical world through medical software, image processing, diagnostic support, home monitoring, etc… but all software used in a medical environment is not necessarily subject to medical regulations. Even the definition/designation of Software as a Medical Device (SaMD) can vary from country to country.
Brexit impacts the medical device markets of Scotland, England, Wales and Northern Ireland. Learn more on the consequences for manufacturers that place medical devices on the UK market here.
In the field of regenerative medicine, advanced therapy medicinal products (ATMPs) represent the next generation of medicines. It is, however, not so straightforward to translate this new expertise into a GMP process. In this article, you’ll learn more about the challenges and crucial aspects.
Sports, competitiveness, team spirit, joy and social responsibility have always been an essential part of QbD and TRIUM’s DNA. So – to celebrate both our 10-year anniversaries – we came up with an exciting event combining all of these values: our 10Y International Sports Challenge!
For four weeks – from 14/06 until 11/07 – we put our best foot forwards to complete the challenge and had a blast. Read all about it below!
The “funny” thing about bringing medical devices to market is that you first must ask yourself… whether your product IS a medical device or not, as well as in which countries it is and in which countries it is not. If your product is classified as a medical device, then it might be subject to constraints. On the other hand, your product might be or be perceived as more valuable, more safe, more performant to customers. Most of the time, however, the choice is not up to manufacturers. All depends on the market(s) you want to reach. Definitions vary from country to country, as do regulations. In this blog post, we will help you answer that one important question by sharing a brief overview of important regulations, their similarities, and their differences.
Risk management, the key to medical device safety, involves much more than ticking the FMEA box. Jeroen Verhoeven, one of our specialists in the matter, explains why and guides you through the ISO14971 standard (application of risk management to medical devices).
Now that it seems like we’re finally taming the COVID beast, many companies are preparing to make the switch to ‘hybrid working’: combining working from home with going back to the office. This concept, however, is not as self-explanatory as you may think. How do we make sure our people work as comfortably at home as they did at the office? Which types of tasks are we going to perform at home and which ones at the office, with efficiency and well-being in mind? And which role does the office still have to play in all of this? At QbD, we’re going the extra mile to put the new way of working to everyone’s advantage. If you need some inspiration, just follow our lead.
ATMPs are, by nature, highly complex and innovative therapies. And well-designed clinical trials are key to producing effective and safe ATMPs – ultimately increasing patients’ health and speeding up market authorization. In this blogpost, Marie-Paule Gyselen from TRIUM Clinical Consulting (part of the QbD Group) guides you through the most important ATMP-specific clinical trial challenges.
Launching a medical device requires much preparation. As these devices are heavily regulated, a company has to meet many requirements in different phases of the development and manufacturing process. Which phases are there to consider and what are their characteristics? This blog digs deeper into the lifecycle of a medical device and requirements that must be met in those phases.
Not sure where to start when validating your computerized systems? Follow these 10 steps as a guideline.
In the smart factories that came with Industry 4.0, digital twins of manufacturing processes are key to improving process robustness, development lead times and ultimately reducing costs. In this blog Evan Claes and Tommy Heck from our partner Antleron explain how digital twins work and why they are so vital, especially to ATMP manufacturing.
In this blog post, we give more insights into the challenges a QP faces when dealing with ATMPs. We talk about sterility, out-of-specification handling, batch release, and EU import testing.
The sales price of cell and gene therapies is influenced by multiple factors like Cost of Goods (COG), regulatory requirements, target market (or commercial aspect), and the development just to name a few. In this blog post you will learn more about the GOC aspect: what is this cost comprised of and how can you reduce it?
UDI is a new system that assigns a unique barcode to each individual medical device. It will become mandatory when MDR and IVDR enter into force, so as a manufacturer, you need to make sure you’re UDI-ready in time.
During the QbD Corona World Games, our online international team building event, thirteen randomly selected teams defended their honor.
A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace the Medical Device Directive (MDD) in May 2021. The regulation has been written to assure better quality and improve the safety aspects for all medical devices that
One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by leveraging the latest technological advancements. It is undeniable that the future of medical technology looks exciting and, obviously, being innovative requires a lot of specific technological expertise
Do you want to distinguish starting materials used for ATMPs from those used for transplants or transfusions? This distinction is made based on how the starting materials are processed and/or used clinically. We’ve listed the steps to make such a distinction, with the help of a flowchart. Current ATMP workflows
Recently, we announced that Quality by Design and TRIUM Clinical Consulting have joined forces to create an end-to-end offering for the lifecycle of medical products and therapies. A giant leap forward in the growth, expansion and development of both companies. Are you curious as to why TRIUM is the ideal
Among the Advanced Therapy Medicinal Products (ATMPs), in the immunotherapy market, nowadays two acronyms catch the eye: CAR-T and TCR-T. The two techniques are based on the insertion of a specific receptor on the T-cells to enable them to detect and kill the tumor cells specifically. When the receptor is
It’s obvious that product quality and patient safety are a top priority in the pharmaceutical industry. The quality by design methodology is used to build quality into production processes. By a comprehensive understanding of and insight in products and processes, continuous improvement of products and processes is possible. But how
GxP Processes Without question, the impact of GxP processes such as product quality and patient health are at the top of the list when it comes to assessing the risks of a computer system. These are crucial in deciding whether to validate a computerized system. Therefore, experience and end user
What does an automation pyramid entail? An automation pyramid visualises the integrated layers of technology used in manufacturing or industry combined with the level of control. From the bottom, where the production runs on motors, machinery, actuators, sensors and so on, to the top where the process is managed. How
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Have you read our earlier blogposts about the The importance of a dedicated team and skilled project manager for technology transfers, the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Until now, academia and research-based companies have been the major source of successful ATMP (gene therapy and cell- or tissue-engineered product) developments. Based on their success, pharmaceutical companies are trying
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Checking your phone to see when you took your last medication? Your watch vibrating and telling you to lay down because you will have a seizure soon, while at the same time notifying your emergency contact with your exact location?
Have you read our earlier blogposts about the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Life sciences enterprises in for example the pharmaceutical, biotechnology and medical devices industry must validate computer systems that have an impact on the product and thus the patient safety. A computer system consists of more than just software and hardware; it includes procedures, processes, equipment, training and much more. In
On the 4th of May, it was the turn of Maaike Tuinsma (Pharmaceutical Consultant at QbD) to give the Biomedical Engineering students of the University of Liège a lecture. Topic of this week: FDA & Medical Devices.
In this blogpost, we will dive into these complexities a little bit more and provide you with some useful tips to minimise the complexity of your tech transfers.
Monday 27 April, the fourth QbD guest lecture was on the agenda for the Biomedical Engineering students of the University of Liège. This time the students were introduced to software as a medical device and validation & qualification by QbD’ers Bart Verlinden and Pieter Smits.
(This blog is part of a series. Want to read the first part? Check it out here) After the Easter holidays, QbD resumed its guest lectures for the biomedical engineering students at the University of Liège. This week, our experienced consultants Jeroen Verhoeven and Steven Vinckx introduced them to the
A technology transfer can take place between buildings on the same production site, between different production plants from the same company or even between different companies. It can involve the transfer of various aspects, such as information, expertise, processes and assets. Thorough understanding between the sending and receiving units is
This blogpost aims to provide useful information for parties involved in the development of face masks in the fight against the COVID-19 pandemic. It lists the impact of the recommendations from the European Commission [1] on the development and distribution of face masks. In general, two types of face masks
Innovation is key to the success of companies and is driving many industries. This is certainly true for the medical technology sector. According to yearly research by the European Patent Organization (EPO) on filings and applications per field of technology, 13.833 med tech patent applications were filed in 2019. Contrary
A hiring freeze during Corona? No way! Although the current crisis has created new and unexpected challenges, QbD is not the kind of company to let these get in the way. In order to keep getting things done for our clients, our HR department is going the extra mile to
As long as the COVID-19 measures are in place, the QbD recruitment team continues to work from home. But thanks to modern technology, and our ‘getting things done’ mentality, it’s business as usual at QbD! Wondering what a working day looks like for our recruiters Tim and Karen? 9.00 am:
Hi! My name is Frederick Tison. I’m 26 years old and this is my third year at QbD. I’m currently active as a raw material specialist for a client. Together with fellow QbD’er Tijs Van Den Berghe, I’m responsible for setting up specifications for the raw materials that are purchased
What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer ground-breaking new opportunities for the treatment of disease and injury. ATMPs can be classified into three main types: Gene
The next episode in the guest lecture program for the students Biomedical Engineering at the University of Liège was a new experience for both trainers and trainees. Some social distance had to be covered by means of a webinar and some high-end glass fiber internet cabling. From our Kot in
As you know, QbD is a very sporty and healthy organization. Since today is the start of homework and social distancing week 2, we obviously miss our weekly Bootcamp together. But thank god for technology! We were able to set up a Bootcamp via livestream in collaboration with our beloved
There we were, in the ‘quartier Polytech’, looking for the department ‘Aérospatiale & Mécanique’ at the university of Liège. We had gotten up way too early in the morning, but a small holiday feeling at 8 AM on Monday was our reward, as we crossed the language border – Liège
Advanced therapy medicinal products (ATMP) is the group of therapies in which we use cells, genes, engineered tissues and combinations of the above with medical devices as a medicinal product. A medicinal product can be described as: any substance or combination of substances presented as having properties for treating or
Advanced therapy medicinal products (ATMP) are cell and gene therapies that provide new opportunities for the treatment of a variety of diseases and injuries. Due to the specificity and novelty of the ATMP sector, the development of these therapies faces a unique set of challenges. Artificial intelligence (AI), a broad