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QMS compliance

QMS compliance

As more manufacturers come into contact with the requirements of the QMS, they're contacting consulting firm IMed for assistance. The company's consultants can help them determine if their products are classified as medical devices, and can train them on regulatory requirements. Because their experience comes from the medical device industry, they are equipped to help their clients deal with practical questions. In addition to training, they can provide guidance on the proper implementation of the QMS.

In the EU and EFTA, distributors of medical devices must obtain a certificate from a Notified Body attesting to their compliance with EU MDR Article 16(3). While it might seem logical to follow ISO 13485, it is not yet an official standard. However, it is a requirement for distributors of medical devices. If you're considering implementing a QMS, you'll want to consider the benefits.

ISO 13485 is an international standard for medical devices. Moreover, it is a mandatory requirement for organizations to meet EU MDR Article 16(3). This standard is logical and easy to follow, but it has not yet been made official by the EU. For example, if you're an EU/EFTA medical device distributor, it's best to use ISO 13485 certification. In addition, it is a good idea to implement a medical device QMS that is based on a modular platform.

Lastly, QMS certification is an important factor for the sale of medical devices. It is important to comply with the requirements of the European Union and the US FDA. Companies selling to the EU typically follow the ISO 13485 standard, although this is not mandatory for companies selling in Canada. In the US, however, companies that sell medical devices in Europe and Canada are usually required to follow the Quality System Regulation of the US Food and Drug Administration.

For medical devices, QMS certification is a prerequisite for sale in major markets. For instance, in Europe, device manufacturers must comply with the Quality System Regulation (QSR) of the US FDA. If you're selling medical devices in the US, ISO 13485 is a mandatory standard for these products. As a result, ISO 13485 certification is crucial for medical device manufacturing. The FDA's Quality System Regulation requires that you implement a quality management system.

In addition to the ISO 13485 standard, the ISO 13485-certified device must comply with the requirements of the MDSAP program. It is imperative to document the design and manufacturing process to ensure that the device meets the requirements of the MDSAP, a QMS must meet these requirements. The FDA requires that all components of the medical devices meet the required safety and efficacy standards. In other words, ISO 13385 applies to every organization involved in the life cycle of a medical device.

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