- IMQ certifies first product to the Medical Devices Regulation

Sweden & Martina S.p.A. receives IMQ first MDR conformity certificate 

Milano, September 23, 2020 – After being among the first Notified Bodies to operate under the new European Medical Devices Regulation (EU) n. 2017/745 (MDR), IMQ is now among the first to deliver an MDR certificate.

"Since we received the notification to operate as Notified Body for the MDR Regulation, in IMQ we have strengthened the staff operating in this Area" said Bernardino Venturelli, Medical Devices Manager of IMQ. "We are committed to ensuring the healthcare sector continuity in the certification of Medical Devices and, therefore, a constant supply of safe products, avoiding any impasse or negative impact that the transition to the new Regulation could have entailed".

The certification issued to Sweden & Martina, a leading Italian company at international level in the design, production and distribution of dental implants and products for the dental world, concerns IR class products, a new class introduced by MDR and related to reusable surgical instruments. 

"Obtaining the certificate under the new MDR Regulations is a source of pride for us" comments Elisabetta Martina, CEO of Sweden & Martina. "It guarantees that our company is equipped with a quality management system capable of ensuring compliance with aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, functional testing and related instructions for use".

The inclusion of reusable surgical instruments in the new MDR is one of the novelties of the Regulation wanted by the European Commission with the aim of increasing the level of safety for patients. These are in fact essential products for the correct application and/or removal of implantable devices and therefore contribute significantly to the safety of surgery.

The issue of one of the first MDR certifications to an Italian company by an Italian Body, one of the few notified at European level and the only Italian one, is further evidence of the role of excellence and avant-garde that our country plays in the medical device manufacturing sector.

About SWEDEN & MARTINA
The group, established in 1972, is currently an international leader in the design, production and distribution of products for the dental sector, especially implantology, an area in which it has achieved the world's highest growth rate.
The company, which is completely privately owned, still belongs to the Martina family.
Enhanced production facilities occupying a covered area of over 2,000 sqm, for a total of 4,000 sqm, are our practical response to the increasing demand for the implants produced here. Three new blocks adjoining the Medical Bioengineering and Production Buildings, designed with a strong focus on functionality but following the same criteria of elegance and aesthetics that have always distinguished Sweden & Martina‘s buildings, are now housing the CNC machine tools, the automated washing systems and a sandblasting unit.
A refurbished area is devoted to prototyping all products under development, and even more space is dedicated to quality control, since despite the continuing growth in the number of items produced, Sweden & Martina is pledged to maintaining its firm commitment to quality, guaranteeing as always 100% checks on all its products.

 

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