Certification of the quality management system for medical devices in accordance with MSZ EN ISO 13485:2016 standard
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Steps of certification procedure
General terms and conditions
Quality and safety are fundamental aspects in medical technology, therefore organizations operating in the medical device market must prove their ability to provide medical devices and related services that continuously meet customer expectations and the relevant regulatory requirements.
The MSZ EN ISO 13485:2016 standard is an independent management system standard, which is based on ISO 9001:2008 standard and contains additional profession-specific, unique requirements for the quality management system of medical devices, from the design of the medical device to its use. It is essential that these requirements for the quality management system are complementary to the technical requirements for the products which are necessary to meet customer requirements and regulatory requirements on safety and performance.
The requirements of this standard are valid to all organizations, regardless of their size and type, who are interested in one or more stages of the lifecycle of medical devices, including the design, development, manufacture, storage, distribution and installation or service of the medical devices, as well as the organisations, who provide, design, develop the related services (e.g. technical support) also including suppliers or other external partners who provide products (e.g. raw materials, components, parts, medical devices) and services (e.g. sterilization, calibration, distribution, maintenance) for these organizations.
The aim of this international standard is to facilitate the global harmonization of regulatory requirements for the quality management systems of organizations involved in the supply chain of the medical devices.
Although it does not contain requirements typical of other management systems: such as environmental management system or occupational health and safety management system, but it allows the organization to harmonize its own quality management system with the requirements of other relevant management systems.
On a voluntary basis, as part of a contractual requirement, or in order to comply with other legal regulations, the organization may decide to use an independent certification body to evaluate how well the organization is able to meet customer and regulatory requirements for the quality management system, as well as the organization's own requirements.
The advantages of a certified quality management system:
• use of the certificate and the certification mark of an independent, third-party certification body as a proof of compliance with the requirements of the quality management system standard.
• an internationally recognised IQNET certificate will also be issued after successful certification
• collecting of possible extra evaluation points during procurement procedures and tender evaluations
• increasing customer satisfaction by demonstrating commitment to meeting customer requirements
• can provide added value to manufacturer conformity assessment procedures for low-risk (I.) devices (except sterile and equipped with a measuring function) and to the certification carried out by organizations designated by local regulations (European certification bodies) for medical devices with a higher risk classification, which is an EU requirement for the manufacture of medical devices, its distribution and use within the European Union (see European Parliament and Council Regulation 2017/745 (MDR) and 2017/746 (IVDR)).
What shall you do if you want to be our client?
If you are interested in our offer, you can receive the necessary information from one of our certification managers on our contact details. Or alternatively please fill out our "Request for Quotation" form and send it to us. We will welcome you among our clients with pleasure and will send you a customized quotation as a reply.
For any questions please contact us with confidence.
Contact persons:
Mrs. Izabella Dávid Szamosi
phone: 06 1 456-6933
e-mail: i.david”at”mszt.hu
Mr. Levente Biacsi
phone: 06 1 456-6930
e-mail: l.biacsi”at”mszt.hu