News

New Certification Body: SIQ Ljubljana

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 [...]

Thursday December 20th, 2018 By News Comments Off on New Certification Body: SIQ Ljubljana Read more...

Public Procurement and Clinical Outcomes

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 [...]

Wednesday March 22nd, 2017 By News Comments Off on Public Procurement and Clinical Outcomes Read more...

Successful Implantation of a Personalized Pelvic Implant

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 [...]

Friday March 17th, 2017 By News Comments Off on Successful Implantation of a Personalized Pelvic Implant Read more...

Unannounced Audit 2017

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 [...]

Friday February 24th, 2017 By News Comments Off on Unannounced Audit 2017 Read more...

Instrumentaria Visits Azerbaijan

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.

Friday November 4th, 2016 By News Comments Off on Instrumentaria Visits Azerbaijan Read more...

Instrumentaria at Moldmedizin & Moldent (2016)

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 [...]

Thursday September 15th, 2016 By News Comments Off on Instrumentaria at Moldmedizin & Moldent (2016) Read more...

ECDE renewal

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 [...]

Thursday September 15th, 2016 By News Comments Off on ECDE renewal Read more...

Recertification Audit 2016

As part of the recertification audit conducted by SGS UK, a team of auditors spent three days at the Instrumentaria manufacturing facility. During the audit, each department was thoroughly reviewed, along with the functioning of the quality management system and compliance with EU legislation applicable to manufacturers of medical devices. The auditors did not identify any significant non-conformities, as confirmed by the final audit report. Instrumentaria’s quality management system complies with the requirements of EN ISO 13485:2012, and a new [...]

Thursday September 15th, 2016 By News Comments Off on Recertification Audit 2016 Read more...

Production and Cooperation Agreement signed with the LLP Sultan

In the office of the President of the Croatia, Instrumentaria signed agreement on long-term cooperation and production with the Kazakhstan Company LLP Sultan. This contract represents a continuation of cooperation with the company in the realization of a joint venture project. Participation in this project and a partnership with a Kazakh private sector will faciliate the expansion of business cooperation to a new market with which Instrumentaria has long term plans in terms of sales of its products, technology [...]

Tuesday June 7th, 2016 By News Comments Off on Production and Cooperation Agreement signed with the LLP Sultan Read more...

IN-Tibial Nail training

At the Instrumentaria premises, our clients were introduced to Instrumentaria’s IN-tibial nail. Dr. Marijan Cesarec presented the basic characteristics of the implant to Croatian traumatologists and demonstrated the procedure for inserting the tibial nail using Instrumentaria’s implantation set. With its design, specifications, and locking options, the tibial nail covers a wide range of indications related to lower leg fractures, while the accompanying instrument set significantly simplifies the implantation procedure through its ease of use. Alongside the presentation of the [...]

Wednesday March 9th, 2016 By News Comments Off on IN-Tibial Nail training Read more...