March 31, 2024

Silmet site and QMS was audited in December for MDSAP/MDR transition and ISO13485:2016, we are proud to share with you auditors comments and findings

The QMS has been appropriately updated to meet the requirements of MDR 2017/745. The company had documented a quality management system in accordance with the normative and regulatory requirements. The management system is based on the requirements of ISO 13485, EC Regulation 2017/475 and the country-specific requirements from Canada (SOR/98-282, Part 1) and USA (21 CFR Part 820 ff)

Appropriate measures are taken to achieve the quality objectives. Major KPIs were monitored, evaluated, and reported to the parent company on a monthly basis. According to the company QMS documentation, interviews with the employees and activities observed, Silmet does not outsource processes in the scope of the certification. The company has evaluated opportunities and risks for the products manufactured by the company and is constantly reviewing new opportunities and risks within its sphere of influence The orientation of the QM system to the safety of medical devices is high and has proven itself. Management Review records dated January 2022 over the company performance in 2021 were reviewed. Examples: improvement of packaging process in order to reduce % of customer complaints – number of inspection in the packaging process was increased; reduction of customer complaints by 5% was achieved. All internal audits (100%) were performed as planned. Training plan was implemented completely (100%). Review of laboratory tests of the products provided sufficient results for all items tested. All customer complaints were investigated and response were sent to the customers. The company as implemented a new system for control of materials using barcode; implementation of new software for labelling and use of scanner for kitting. Silmet has made effective arrangements for gaining experience from the post-production phase, including postmarket surveillance, handling complaints, and investigating the cause of nonconformities related to advisory notices with provision for feedback into the Measurement, Analysis and Improvement process. The company has determined the applicability of unique device identifier requirements per 21 CFR 801 and 21 CFR 830, has obtained the unique device identifiers from an FDA-accredited UDI-issuing agency, and the required data elements have been entered in the Global Unique Device Identification Database (GUDID). Performance per product was evaluated. Customer satisfaction for restorative materials was between 90% and 96%, amalgam 95%, adhesive between 93.4% and 95%, glass ionomers – 90%. With regards to packaging – satisfaction was 89.8%, delivery – 83.8%. Final result, 3 minor non conformities all of which were addressed and closed Silmet will continue to be in the forefront of ongoing regulation changes.