Device Certificates

All devices are subject to the highest safety standards and have worldwide approvals for safe operation.

MOT South

In the medical sector, the demands on products are particularly high because strict quality standards must be met. In this demanding environment, advice from technical experts is invaluable. TÜV SÜD, a leading provider of certifications, has more than three decades of experience in quality management for medical devices. Through continuous training, the company has acquired comprehensive specialist knowledge and occupies a leading position in countries with strict medical device regulations.

Certification by TÜV SÜD confirms compliance with internationally recognized standards, in particular ISO 13485. For manufacturers, this means solid proof that their production processes meet the highest quality requirements. This strengthens their reputation, promotes the trust of regulators, buyers and users and offers clear competitive advantages.

Manufacturers who do not have certified quality management systems often face significant hurdles in obtaining approval for their products in major markets. This can lead to delays in market entry and potential loss of sales.

ISO 13485 test seal / test standard

Certifications create trust - and this is particularly crucial for medical devices. The international standard EN ISO 13485 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 standalone document, ISO 13485 is largely identical to ISO 9001. While ISO 9001 requires that the organization as a whole must strive for continuous improvement, the core requirement of ISO 13485 relates to product safety. Here, the effectiveness of the processes introduced is intended to ensure that the product's requirements are met. ISO 13485 contains detailed requirements on topics relating to the manufacture and marketing of medical devices.

Medical devices – test seal

The EN ISO 13485 standard “Medical devices: Quality management systems – Requirements for regulatory purposes” addresses the requirements that manufacturers and suppliers of medical devices must meet when 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 but also the regulatory requirements of the European Union (EU), Canada and other major markets worldwide.

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

ECM – Duck Certification Macchine

Ente Certificazione Macchine is a notified body authorized by the European Commission to issue EC certificates in accordance with Directive 93/42/EEC (MDD). [See the ECM accreditations on the European Commission's Nando Information System 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 Devices Directive 93 /42/EEC (MDD) lists the essential safety, efficacy and quality requirements that a medical device must meet in order to receive 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 must be applied using the same technique.

CE stands for Communauté Européenne (European Community). The marking indicates that a product or machine complies with the relevant European directives. The CE mark, introduced in 1995, can therefore be understood as a “passport” for machines, as it allows machines to be both marketed and operated in the EU. It is important that the CE marking is not confused with a seal of approval or quality mark.

FDA
Approval by the Food and Drug Administration (FDA) is one requirement to distribute medical devices in the United States; the other is working with a qualified distribution partner.

Almost all medical device manufacturers supplying the American market must implement a quality management system that complies with FDA regulation QSR 21CFR820 or the Quality System Regulation. The FDA QSR requirements are similar to those of the European ISO 13485, but there are special features and the FDA does not recognize the ISO 13485 certificate.