Engineering and development of quality management systems; products for medical use - systems for regulatory purposes (ISO 13485)
Purpose
Controlling and reducing errors and failures encountered by businesses producing medical devices daily requires the systematic management of processes, the adoption of appropriate measures and the certification CE of the products.
Framework
The European Norm, EN ISO 13485:2012 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, issued after the approval of CEN on January, 24 th 2012 and replaces the EN ISO 13485: 2003, although the basic text has not changed (only the prologue and some minor changes to the annexes). This was done to bring the standard into line with the framework and requirements for issuing the Certificate of Compliance (Annex 2 and Annex 5 of Directive 90/385/EEC AIMD; Annex II, V and VI of Directive 93/42/EEC MDD; or Annex III, IV and VII of Directive 98/79/EC IVDD).
Our services
Having as a main objective the total customer satisfaction, we develop, maintain, improve and upgrade reliable systems and structures in companies that already have or do not have organized departments and management systems for medical products and devices (ISO 13485).
We look for the issue of Technical File, the implementation of analysis tests related to the product.
The system (ISO 13485)
The International Organization for Standardization (ISO) has already replaced this version by ISO 13485: 2016 but given the three-year transition period that follows all standards, the new version becomes mandatory from March 2019 (since the new standard was issued in March 2016).
Through the implementation of the Quality Management System imposed by the standard, it is ensured that:
• the legal and regulatory requirements related to the movement of products and their CE marking are applied, where appropriate
• decisions are made on the basis of analysis and systematic measurements based on the process-based approach
• the resources required for continuous improvement are provided and the application of these principles and procedures is reviewed by the company’s top management
Contact us for further information for any questions you may have or any clarifications you may need.
