The most frequently asked questions about the quality management system
This FAQ provides answers to the most common questions that companies such as medical device manufacturers have about quality management systems (QM systems) and ISO 13485.
Inhaber der Johner Institut GmbH
Phantoms in medical technology
Phantoms in medical technology help to develop, validate, “approve” and monitor medical devices in the markets faster and more effectively. This article describes which organizations particularly benefit from the use of these phantoms and what requirements they must meet.
DetailsWhat manufacturers need to know about legacy devices
Legislators are continually changing the regulatory framework for medical devices, as we have seen in Europe with EU Regulation 2017/745 (MDR) and EU Regulation 2017/746 (IVDR). This then raises the question of how to deal with legacy devices. These are the medical devices that manufacturers have legally placed on the market under the old directives…
DetailsDigitalization of the production
The digitalization of the production is an essential part of the digital transformation of manufacturing companies. However, not all companies benefit to the same extent from digitalization. This article describes,
DetailsMDCG 2023-4 on combinations of MDSW and hardware
MDCG published guideline MDCG 2023-4 in October 2023 entitled “Medical Device Software (MDSW) – Hardware combinations – Guidance on MDSW intended to work in combination with hardware or hardware components.”
RIMS: Future or anchoring in the past?
Medical device manufacturers have high expectations of Regulatory Information Management Systems (RIMS). The costs and efforts involved are immense and usually much higher than expected. The benefits, on the other hand, are not clear. This article will give you some hints,
DetailsPFAS ban: You must act immediately!
With PFAS, the EU plans to ban an entire class of chemicals. In doing so, it is not only threatening the supply of medical devices but also the competitiveness of EU manufacturers. After all, the assumption that manufacturers inside and outside the EU are treated equally is just one of the EU’s five misconceptions in…
DetailsRegulatory Intelligence – a core task of regulatory affairs?
Many companies consider Regulatory Intelligence so important that they create their own roles and departments for it. This article clarifies what Regulatory Intelligence is, how companies can benefit from it, and where tools can provide support.
DetailsDevelopment process: Lean and compliant with standards
Laws and standards formulate requirements on how medical device manufacturers must define and document the development process. Notified bodies check these requirements during audits. This article on the development process provides tips on how to design the process and how to align it with other processes, such as the risk management process.
DetailsDevelop software components compliant with IEC 62304 and FDA
Medical software manufacturers must meet the legal requirements for software components in order to “approve” their devices. This article presents these requirements and gives seven tips on how to fulfill them quickly and easily.
Details