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.
Labquality and Mectalent Medical Services have merged.
Labquality Ltd and consulting company Mectalent Medical Services Ldt (MMS), both part of COR Group, have merged. The new company will continue operating under Labquality’s name and invest heavily in product development.
The merger will combine the operations of two companies that are focused on developing the quality in healthcare and social services sectors, both being top experts in their line of business: Labquality in quality assessments and quality assurance for medical laboratories as well as certification and education services and Mectalent Medical Services in medical device and IVD-device registrations worldwide.
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.
Authorized EC Representative
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.
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).