Echolight is pleased to announce that a new process to improve the company organization has been successfully completed, this time aimed at internationalization
In the first weeks of 2022, the international body DQS Medizinprodukte GmbH based in Frankfurt am Main (Germany) issued the MDSAP (Medical Device Single Audit Program) certificate to Echolight Spa.
It is one of the most recent quality standards for the electro-medical sector and specifically concerns the definition of the requirements of the quality management system of companies that design and manufacture medical devices.
A single audit for medical devices
The MDSAP program allows the bodies accredited by the Regulatory Authorities of the five participating countries to carry out a single audit aimed at verifying that the equipment produced meets the management requirements of the Quality System of the reference countries.
The audit was conducted on the basis of accredited procedures and certified that the Apulian company has implemented an adequate Quality Management System (QMS), with specific reference to the sector of ultrasound medical devices and related quantitative and qualitative diagnostic software, analysis of the musculoskeletal system and multispecialistic applications.
This is the detail of the participating agencies:
- AUSTRALIA – Australia Therapeutic Goods Administration of Australia (TGA)
- BRAZIL – Agência Nacional de vigilância sanitária (ANVISA)
- JAPAN – Japanese Ministry of Health, Labor and Welfare (MHLW)
- CANADA – Health Canada (HC)
- USA – Food and Drug Administration (FDA)
This opens up a further international scenario for the company.
A palmares of certificates
MDSAP is the latest recognition in order of time that is combined with a very well structured quality system.
To date, Echolight holds the following certifications (all issued by Kiwa Cermet Italia):
- ISO 9001: 2015 which is the basic standard for the regulation and systematization of company management procedures;
- ISO 13485: 2016 which expressly concerns companies that design and produce electro-medical devices, ascertaining their quality and safety requirements. The standard is in fact a precondition for the CE mark and also for the just obtained Medical Device Single Audit Program.
These are the different organizational areas that Echolight has certified on the basis of the ISO 13485 standard:
– the design,
– Development,
– production,
– distribution,
– installation,
– technical support.
- CE mark (in compliance with Directive 93/42 / EEC): it certifies that medical devices comply with a series of essential requirements for being placed on the Community market. These include the safety and protection of the patient and operator, as well as the protection of the environment.
We will go further. Ad maiora semper.
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