User experience is not usability
Many companies confuse “user experience” with “usability,” which leads to confusion not only during audits. This article distinguishes between the two terms and reveals how you can test both.
Quality objectives and quality policy: When leaders are too lazy to think
Regulations such as MDR and ISO 13485 require manufacturers to define quality objectives and a quality policy. These are prerequisites for the conformity of the QM system and thus for obtaining the associated certificate.
C5 certificates also for medical device manufacturers?
C5 certificates are relevant for service providers and, where applicable, for medical device manufacturers. The German Digital Act (DigiG), which came into force at the beginning of 2024, redefines the requirements for cloud services in the healthcare sector. This article explains the most important aspects of C5 certification for medical device manufacturers and service providers…
DetailsQM document control: How many fail audits
Document control is a documented procedure that specifies how documents are created, reviewed, approved, labeled, distributed, and updated. Organizations certified according to ISO 9001 or ISO 13485 are obliged to document control.
DetailsInternal audits: Objectives, requirements, methods
Internal audits are inspections of the quality management system (QM system) and its processes by the organization itself. This is why they are also called 1st party audits. ISO 13485 requires internal audits like its “sister standard,” ISO 9001, and other standards and regulations. Therefore, internal audits are also a subject of external audits and…
DetailsApplicability of the AI Act to manufacturers as operators/deployers
This article examines the AI Act’s applicability to manufacturers of medical devices and IVD that do not place AI-based devices on the market. Among other things, it answers the question of whether a manufacturer must comply with the AI Act if he uses ChatGPT or develops an AI system that classifies customer feedback for his…
DetailsCreating standard operating procedures for QM
In a standard operating procedure (SOP), companies define their processes, for example how they develop medical devices or provide services. Standards such as ISO 9001 and ISO 13485 require standard operating procedures. Companies can define these specifications in their quality management manual directly or in independent documents.
DetailsHarmonized standards: Evidence for medical device manufacturers
Most 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.
European Health Data Space EHDS: An overview for medical device and IVD manufacturers
Regulation (EU) 2025/327 on the European Health Data Space (EHDS for short) is another European regulation that may affect medical device and IVD manufacturers. This article explains what this regulation requires and what these manufacturers have to do by when, as well as the possible advantages of the EHDS and the EHDS Regulation.
DetailsProduct liability: medical device manufacturers pay attention!
Neither the MPG nor the MDR contain regulations on product liability, i.e., manufacturers’ liability for harm caused by defective devices. However, manufacturers should be aware that a lot of legal regulations entitle injured persons to claim compensation if a defective medical device causes harm to a patient, user, or third party. Liability may result, for example,…
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