Use the tags to quickly find relevant articles. Click on the respective tag (shown below as links). This will take you to a brief introduction to the topic and, below that, to all the corresponding articles.
Legal areas, regulations, authorities
Most articles provide advice that is helpful in all legal areas. However, if you are looking for information that is specifically relevant to a legal area, a regulation, or an authority, then use these keywords:
- FDA
- International approval
- German laws and regulations
- Medical Device Regulation MDR (2017/745)
- Medical Device Directive 93/42/EWG (MDD)
- Notified bodies
- BfArM
Roles
Select the articles according to your role:
- Beginners who are new to the subject
- Management and executives (managing directors, vice presidents, CxOs, …)
- Hospitals, laboratories, practices, and other operators
As a subject matter expert, you can get an overview of the articles relevant to you directly via the respective categories:
- Regulatory affairs and approvals
- Quality management and ISO 13485
- Risk management and ISO 14971
- Usability engineering and IEC 62366-1
- Software development and IEC 62304
- Systems engineering
In addition, use the tags shown in the following text.
Product type
The following tags filter the articles according to product type:
- In-vitro diagnostic medical devices (IVD)
- Medical technology – medical equipment – active medical devices
There are additional tags for devices that contain software or are software:
- Medical software
- Clinical information systems
- Standalone software
- Mobile medical apps
- Digital health applications (DiGA)
Regulatory cross-cutting topics
The following tags are largely independent of the legal area and product types:
- Qualification and classification
- Requirements, stakeholder requirements, system requirements
- General Safety and Performance Requirements (GSPR)
- Technical documentation for medical devices
- Clinical evaluation
- Validation
- Conformity assessment procedures and audit
- Processes and procedures
- Post-market phase
Specialist topics
Risk management
And more
Other topics
At the meta-level, it is important to adapt your organization continuously to meet regulatory requirements and remain competitive. This is because the environment (e.g., competitors, technologies) constantly changes.
Please refer to the articles on the keyword (tag) transformation projects.
Haven’t found what you’re looking for? You can get free answers in our micro-consulting.
Benefit from the help of the Johner Institute. We help you develop your medical devices quickly and in compliance with the law and bring them safely to market through audits and approvals. Get in touch.
