Quality Management & Regulatory

Mark Medical group is registered and organized for the distribution of medical devices and medicinal products for human use. Dedicated resources in each country organize and manage the execution of all procedures and policies that assure law requirements (i.e.: product registrations in countries that are not part of the European Union), directives of National Competent Authorities as well as International Guidelines for Good Distribution Practice and customer requests are being followed.

Well trained personnel, with a strong background in the distribution of medical devices and medicinal products, is constantly updated to meet increasing quality, regulatory and compliance requirements. Effort is made to achieve constant improvement of services, as the Mark Medical group policy is excellence and quality as a standard.

The storage and transport of medical devices and medicinal products is carried out professionally and meets the requirements of the many diverse products we deal with. Our warehouses have controlled temperature, humidity and are supplied with cold rooms/refrigerators to store products that require the cold chain.

Mark Medical has obtained Italian Health Authorities permit to handle and export pharmaceutical products for human use in 2002 and has been active in the pharmacovigilance field ever since. Mark Medical is also active in the vigilance field fulfilling requirements of EU directives and working in close collaboration with National Health Authorities and medical device producers to improve health and safety of both patients and costumers.

MM is ISO 9001 certified.

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Certificate Mark Medical S.p.a. IT - ISO 9001:2015 - view

Certificate Mark Medical d.o.o. SI - ISO 9001:2015 - view

Certificate Mark Medical d.o.o. HR - ISO 9001:2015 - view

Certificate Mark Medical d.o.o. BIH - ISO 9001:2015 - view

Certificate Mark Medical d.o.o. SRB - ISO 9001:2015 - view