Elcon Instruments Ltd has implemented a quality management system, which has been certified to ISO 9001:2015. This certification ensures that the company constantly delivers products that meet all customers’ needs and regulatory requirements and requires that we commit to the improvement of the system and ongoing conformity to regulations.
The system has been audited by SGS UK, which is a UKAS accredited assessor and is subject to successful surveillance audits to ensure ongoing compliance.
We are proud to have achieved recognition as a company certified to the ISO 13485 medical device manufacturing standard.
The key aspects that the ISO 13485 requirements are as follows:
Promotion and awareness of regulatory requirements as a management responsibility.
Controls in the work environment to ensure product safety.
Focus on risk management activities and design control activities during product development.
Specific requirements for inspection and traceability for medical devices.
Specific requirements for documentation and validation of processes for medical devices.
Specific requirements for verification of the effectiveness of corrective and preventive actions.
This deceleration assures that products supplied by Elcon Instruments are in conformity with the essential requirements of the European Medical Devices Directive (93/42/EEC) and are manufactured to the highest standards of craftsmanship following the relevant national and international standards.
We continue to work towards compliance with the new MDR (2017/745). The new regulation will come into force in May 25th 2024.
We are registered with the FDA (U.S. Food & Drug Administration). The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of medical devices in the USA. Our US Agent and Official Correspondent with FDA is Business Support International.