Tvornica proizvoda za medicinu, trgovinu i zastupanje
Rimski put 31, 10360 Sesvete, Hrvatska
MEDICA, the leading international medical trade fair for medical equipment and technology took place in Dusseldorf from 18 to 21 November 2019. World's largest medical trade fair attracted 5.500 exhibitors from 71 countries and more than 120.000 visitors. Medica trade fair was a great opportunity for us to get acquainted with new trends on the market and to establish new business contacts.
The 18th National Conference of Operating Room Nurses of Croatia was held in Tuhelj from October 3 to 5, 2019. We were glad to once again have the opportunity to enjoy pleasant moments in a friendly atmosphere and cheerful spirit with our dear operating room nurses and technicians.
As a silver sponsor, we participated in the First Congress of the Association of Orthopaedists and Traumatologists of Montenegro, held in Budva from September 26 to 28, 2019. The congress brought together leading regional and international orthopaedic and trauma specialists. Together with our distributor for Montenegro, Farmont, we presented our product portfolio.
As of December 5, 2018, the Slovenian Institute of Quality and Metrology (SIQ Ljubljana) has become the notified body for Instrumentaria d.d. SIQ is now responsible for issuing certificates for our Class IIa, IIb, and III medical devices, as well as for certifying our Quality Management System in accordance with ISO 13485. The assessments and certifications are conducted by highly qualified professional auditors, and the credibility of SIQ certificates is confirmed by the Slovenian Accreditation (SA) and the international certification network [...]
Following the presentation of clinical outcomes related to public procurement between 2014 and 2016 at the HALMED conference “New Legislation – A New Direction for Medical Devices” by a representative of Johnson & Johnson, which indirectly associated the Instrumentaria hip endoprosthesis with a significant increase in revision surgeries during the public procurement period, Instrumentaria is obliged to present the results of clinical safety and performance evaluations of its hip endoprosthesis. In accordance with Annex X of Council Directive 93/42/EEC on [...]
In collaboration with the Clinic for Orthopaedic Surgery in Lovran, Instrumentaria has designed and produced a personalized pelvic implant. By closely following all the requirements of the medical team and taking into account the patient’s health status and the biomechanical stability of the implant, Instrumentaria’s development team has created yet another high-quality, customized solution using the latest technological advancements in medical device manufacturing. The implant was produced using 3D printing technology and the most advanced design techniques for osseointegrative implant components. The [...]
In order to ensure continuous compliance with Council Directive 93/42/EEC on medical devices, the European Commission introduced a new regulatory requirement on September 24, 2013, mandating unannounced audits by notified bodies for manufacturers of Class III medical devices. In line with this requirement, on February 22, 2017, the notified body SGS UK conducted an unannounced audit at Instrumentaria. The notified body confirmed that all processes were in compliance with the requirements of Directive 93/42/EEC, and that the quality management system was [...]
As part of the visit of the President of the Republic of Croatia, Kolinda Grabar-Kitarović, to Azerbaijan, Instrumentaria participated in an economic delegation during which initial contacts were established with interested companies in the medical industry sector. Productive meetings with representatives of the medical sector marked the beginning of Instrumentaria’s expansion into yet another market.
Instrumentaria’s portfolio of trauma and orthopedic implants was presented at the Moldovan medical fair Moldmedizin & Moldent (2016). Feedback from the distributor GBG-MLD regarding interest in Instrumentaria products has been extremely positive. Orthopedists and traumatologists attending the congress classified Instrumentaria products as high-quality and easy to implant, noting their excellent biomechanical properties due to design and materials used. The event served as further proof that Instrumentaria implants deliver excellent clinical results, which the market has responded to very well. The successful [...]
Upon the expiration of the five-year ECDE certificate for all hip components, Instrumentaria submitted data on the clinical safety and effectiveness of individual hip components to the notified body SGS UK. By analyzing the results of initiated clinical studies and other post-market surveillance methods, clinical experts from the notified body determined that Instrumentaria’s hip endoprostheses meet the high standards of quality, safety, and effectiveness required by the EU for manufacturers of this type of implant. Preliminary reports from the ongoing [...]
Tvornica proizvoda za medicinu, trgovinu i zastupanje
Rimski put 31, 10360 Sesvete, Hrvatska
