This page is aimed at anyone who needs a quick introduction to the world of medical device law and quality management, for example, because they want to get their devices approved.
Content
You will find the most important information on this page:
The article “In 7 steps to a medical device” provides you with a very quick introduction to the topic of “approval of medical devices” (in Europe).
On this page, you will find a presentation that you can look through in just a few minutes, as well as a detailed description of the seven steps.
The free starter kit contains
You can download the starter kit here.
The “regulatory affairs” page helps you get started and provides an overview of standards and laws. If you are based in Germany, you should be familiar with German laws and regulations. If you are based in the USA, you should be familiar with the FDA requirements.
You should understand
Beginners should also familiarize themselves with these activities at a very early stage:
Under the keywords medical equipment, standalone software, medical apps, medical software, DiGA, and IVD, you will find tips on the individual product categories.
A glossary provides an overview of many terms.
Another article explains to newcomers what causes medical start-ups to fail and how they can avoid this.
The Johner Institute provides you with all the support you need, and not just as a beginner:
Contact us immediately to clarify the next steps so you can bring your devices to market quickly and safely.
The correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the distinction between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…
DetailsIn this article you will learn, 1. Contents of a declaration of conformity Annex IV of the MDR specifies what a declaration of conformity must contain: 2. Scope of a declaration of conformity Don’t declare conformity for an unspecified number of devices. Wording that doesn’t contain any restrictions in terms of applicability does not comply with…
DetailsMost manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example. 1. Standards and harmonized standards a) Definitions and more EU Regulation 1025/2012 defines the term harmonized standard. Standards are documents written by national or international standardization commissions…
DetailsWhat is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article 1. Verification a) Definition This definition does not explain what type of “requirements” need to be confirmed by verification. Limiting these requirements to product or component requirements is recommended to avoid…
DetailsThis 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. Question 1: Who needs a QM system? The EU Medical Device Regulations (MDR and IVDR) as well as the FDA set requirements for QM systems. These requirements are relevant…
DetailsThe QM manual is the top document in the document pyramid of the QM system. It is an entry point for employees and auditors to get a quick overview of the QM system. In this article, you will learn when you need a QM manual, its objectives, and what it should contain. 1. QM manual:…
DetailsMedical device certification, MDR certification, CE certification. These are terms that are used frequently. But is there even such a thing as medical device certification? This article answers the question. 1. Summary The short answer is: There is no formal medical device certification, CE certification, or MDR certification. However, manufacturers do require certifications or certificates.…
DetailsAnytime you want to launch a medical device on the market, you quickly come to the question of which legal regulations you have to comply with. This article will give you answers and present the seven steps to quickly place your devices on the market in compliance with the law. Step 1: Determine if the…
DetailsThe Medical Device Coordination Group (MDCG) has drafted a guidance document that describes how manufacturers should place their class 1 medical devices on the market in order to comply with the MDR. The title of the document is “Guidance Notes for Manufacturers of Class I Medical Devices”. This article provides a summary of the document and gives…
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