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TÜV Süd all diode lasers 

The path to the various markets is paved with strict requirements, especially in the field of medical devices: the products must meet the highest quality standards and their quality management must be designed accordingly. Here it makes sense and is good to be able to consult an experienced expert. Like TÜV SÜD.

TÜV SÜD has been testing and certifying quality management systems for medical devices for over 30 years and has the necessary know-how, not least thanks to the continuous training of its specialists. This is why TÜV SÜD is one of the market leaders in countries with strict regulation of medical devices. Quality management certificates confirm compliance with a whole series of international standards, above all ISO 13485. As a manufacturer, you thus have proof that certified quality management has been applied in the manufacture of your medical devices, which meets the highest requirements. This promotes your image as a manufacturer, strengthens the confidence of authorities, buyers and users in your products, and provides clear sales arguments.

Medical products manufactured or offered by companies that do not have a certified quality management system generally have a harder time getting approved in key markets. This can lead to delays in market entry and lost sales.

ISO 13485 Prüfseal / Prüfstandard all diode lasers

Certifications create trust – and that is especially crucial for medical devices. The international EN ISO 13485 standard is the standard for quality management systems in the medical device sector. This certification is a prerequisite for market entry in many countries. Although it is a separate document, ISO 13485 is largely identical to ISO 9001. Whereas ISO 9001 requires that the organization as a whole strive for continuous improvement, the core requirement of ISO 13485 relates to product safety. Here, the fulfillment of the product requirements is to be ensured by the effectiveness of the implemented processes. ISO 13485 contains detailed requirements on topics relating to the manufacture and placing on the market of medical devices.

Medical devices – Prüfseal all diode lasers

The EN ISO 13485 „Medical Devices Standard: Quality Management Systems – Requirements for Regulatory Purposes“ addresses the requirements that medical device manufacturers and suppliers must meet in developing, implementing and maintaining management systems for the medical device industry. Originally developed in the 1990s, the standard contains requirements for quality management systems that meet customer requirements, as well as regulatory requirements of the European Union (EU), Canada, and other major markets worldwide.

The scope and purpose of EN ISO 13485 is similar to ISO 9001, but it contains additional, specific requirements for medical devices and reformulates some of the requirements of ISO 9001. In most markets, certification to ISO 9001 is therefore not an adequate substitute for certification to the requirements of EN ISO 13485.

ECM – Ente Certificazione Macchine

Ente Certificazione Macchine is a well-known body authorized by the European Commission to issue EC certificates according to Directive 93/42/EEC (MDD). [See the ECM accreditations on the European Commission's Nando Information System qui database]

The CE Mark The CE mark is the mandatory certification mark that every medical device must have in order to be marketed and used in the European Union. The CE mark declares that the product complies with the applicable European directives. The Medical Device Directive 93/42/EEC (MDD) lists the essential safety, efficacy and quality requirements that a medical device must meet in order to obtain the CE mark and be placed on the European market.

EU Regulation 765/2008

The CE marking indicates that the machine meets the requirements of the Machinery Directive. This also applies to all other applicable EC directives. Each machine may be provided with exactly one CE mark. The CE marking must be on an equal footing with the manufacturer's information and be affixed in the same technique.

CE stands for Communauté Européenne (European Community). The marking states that a product or machine complies with the relevant European directives. The CE mark, which was introduced in 1995, can therefore be seen as a passport for machines, as it allows them to be marketed and operated in the EU. It is important to note that the CE marking must not be confused with a quality seal or quality mark.

FDA 510 K
Food and Drug Administration (FDA) approval is one requirement to distribute medical devices in the United States; the other is to work with a qualified distribution partner.

Almost all medical device manufacturers supplying the U.S. market must implement a quality management system that complies with FDA regulation QSR 21CFR820 or the Quality System Regulation. The requirements of the FDA QSR are äsimilar to those of the European ISO 13485; at the same time, there are specifics, and the FDA does not recognize the ISO 13485 certificate.