Medical Devices
Developing a new medical device? Looking to enter new markets and need a sales approval? With vast expertise in registering demanding medical devices, including implantable devices, medical software as well as personal protective equipment, we help medical and in vitro diagnostic device manufacturers acquire CE markings and global regulatory approvals.
EU Sales Approvals
Applying for CE-marking is a demanding and often laborious puzzle that can take several weeks. We make sure that your product and application meet the strict requirements, making it easier and quicker for your company to get a sales approval in the European economic region.
Global Sales Approvals
Our regulatory expertise covers a wide range of countries and in addition to the EU, we have registered devices to over 40 countries including the US, Brazil, Chile, India, Iran, Japan, Russia, Singapore, South Africa, Taiwan, and the United Arab Emirates.
Quality Management Systems
Together with our customers, we plan quality management systems and write quality manuals in accordance with the ISO 13485, ISO 20387, US FDA QSR, and CMDCAS standards – just to name a few.
IVDR Compliance
The new In Vitro Device Regulation (IVDR) will come into force on May 26th 2022. Due to its detailed and complex nature, IVDR places significant needs for both implementation and maintenance. Our strong experience in IVD test kits and instruments, medical device software and mobile applications, ensures that we can support you in getting your Quality Management System and Technical Documentation compliant with IVDR. Our expertise also covers single-use IVDs, companion diagnostics (CDx), and genetic tests.
Authorized EC Representative
If you are a non-European manufacturer and intend to sell a medical device in Europe, you must appoint an authorized EC representative in the EU. We serve as an authorized EC representative for medical device manufacturers outside of the EU who are looking for registration and sales approval in the EU.
Clinical Evaluations
The clinical evaluation of a medical device is a multistage and closely regulated process. A carefully carried out process not only fulfills requirements set by the authorities, but also gives manufacturers valuable information of the device’s performance and properties.
Other services
We also provide internal quality and regulatory trainings, support with product verifications and validations, efforts towards compliance with IVDR and MDR as well as clinical performance evaluations, planning and conduction. Labquality’s experts can also take on the role of Quality Manager and Person responsible for regulatory compliance (PRRC).
