.png?width=109&height=108&name=Pharma%20(2).png)
.png?width=111&height=108&name=Medical%20Devices%20(2).png)
.png?width=84&height=107&name=IVD%20(2).png)
Medical Device Software Compliance
Our service offers a tailor-made framework for medical device software compliance, ensuring adherence to MDR, IVDR, ISO13485, ISO14791, and other key standards. We...
Medical Devices
Are you looking for quality, regulatory or clinical support for your medical device? QbD Group can support you at any stage in the lifecycle of your medical device, from idea to patient.
We are experts when it comes to ISO13485, clinical evaluation/investigation, MDR, design and development, technical files, auditing, qualification, validation, risk management, software, and more.
Our offerings for Medical Devices in
.jpg)
-1.jpg){kind=tracking}
.jpg)
.jpg)
.jpg)
.jpg)
.jpg)
-1.jpg)
-2.jpg)
.jpg)
.jpg)
.jpg)
.jpg)
.jpg)
.jpg)
Industry challenges
Medical devices are regulated by laws that govern the safety and performance of devices across their lifetime, from pre- to post-market. A risk-based classification system determines the requirements for medical devices.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Manufacturers must ensure to only place medical devices in the market that comply with the legislative requirements.
This requires documentation of the design, development, and manufacturing process of the device including sufficient clinical evidence that shows the device is safe and performs as intended.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
.jpg?width=1600&height=900&name=Medical%20Devices%20%20Our%20Industries%20-%20QbD%20Group%20(1).jpg)
Industry challenges
Medical devices are regulated by laws that govern the safety and performance of devices across their lifetime, from pre- to post-market. A risk-based classification system determines the requirements for medical devices.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Manufacturers must ensure to only place medical devices in the market that comply with the legislative requirements.
This requires documentation of the design, development, and manufacturing process of the device including sufficient clinical evidence that shows the device is safe and performs as intended.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
Our services
QbD Group offers a comprehensive suite of services tailored to address the unique needs of medical device manufacturers.
Related offerings
Medical Device Software
In today’s world, medical device software manufacturers are looking to meet the unmet needs of patients and healthcare providers by leveraging the latest technological advances and taking advantage of the vast increase in digitalization.
At QbD Group, we cover the full MDSW lifecycle to support you with all Regulatory, Quality, Clinical, and Design & Development challenges.
Learn more
Why QbD Group?
YOUR MEDICAL DEVICES INDUSTRY EXPERT
Within QbD Group, we have the knowledge and expertise to support manufacturers, distributors, and importers of medical devices in complying with the legislative requirements during the complete lifecycle of a medical device.
Our clinical, regulatory, and quality experts know what needs to be done to be able to comply with the legislative requirements by which a medical device can be safely placed on the market.
Furthermore, we keep supporting businesses by managing the processes that ensure the medical device continues to be safe and effective, before and after placing it on the market.
10+ years of experience
Full lifecycle support
Global presence
Best managed company
Resources
Blog
Blog
Blog
Get the latest industry news
Staying on top of the latest in the life science industry can be a daunting task. This newsletter will keep you up-to-date with the latest news, blogs and webinars so you can keep ahead of the curve.
Connect with us at these events
Industry
Service
February
March
April
May
June
September
October
November
Load More
