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Medical Devices
Are you looking for quality,
regulatory or clinical support for your medical device? Labmark can
support you at any stage in the lifecycle of your medical device, from idea to
patient.
We are experts when it
comes clinical evaluation/investigation, MDR, design and development,
technical files, auditing, qualification, validation, risk management, software, and
more.
How we can help you
Labmark offers a comprehensive suite of services tailored to address the unique needs of medical device manufacturers.
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.
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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.
Why Labmark?
YOUR MEDICAL DEVICES INDUSTRY EXPERT
Within Labmark, 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
East Africa and Global presence
