Quality management for medical devices: Our System for Success.

Quality management systems (QMS) play a key role in the legal requirements for establishing a medical device on the market. An effective quality management system is not only a regulatory necessity, but also a strategic advantage. It ensures that your products meet the highest quality standards and at the same time minimizes various risks with regard to product quality and regulatory requirements. There are various normative and legal requirements, such as the MDR (Regulation EU 2017/745), DIN EN ISO 13485 or FDA 21 CFR part 820, which are being continuously developed and adjusted. At Medicoforum, we offer comprehensive services for implementing and maintaining a QMS that meets the requirements of the MDR (EU 2017/745) and DIN EN ISO 13485. Our expertise covers the entire range of QMS requirements. We advise, design and implement customized systems that are tailored to the specific needs of your company and your products. Implementing and maintaining a QMS requires not only technical knowledge, but also a deep understanding of the regulatory landscape and the specific requirements for medical devices. The continuous development of legal and normative requirements makes it difficult for companies to keep up to date at all times. This is where we provide you with targeted support: Our experts are always informed about the latest developments and can ensure that your QMS complies with current standards and is future-proof. We provide support where you need it – from checklists to accreditation with tailored information. We take care of the quality management of your products. We consult, design and implement systems for quality management according to the individual requirements of the respective product and the associated processes.

What if you don’t have the capacities?

As we have our own QMS (quality management system), customers can implement their product in our system and thus delegate their obligation as a legal manufacturer. This means that you can concentrate on your core competencies while we take on the complex and time-consuming tasks of quality management.