Deutsch: Medizinprodukt / Español: Dispositivo médico / Português: Dispositivo médico / Français: Dispositif médical / Italiano: Dispositivo medico

In the quality management context, a "medical device" refers to any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for a medical purpose. Quality management for medical devices focuses on ensuring that products consistently meet regulatory requirements and customer needs, especially regarding safety and efficacy.


Image demonstrating Medical device in the quality management context
Medical device

Medical devices range from simple tongue depressors and medical thermometers to complex programmable pacemakers and sophisticated imaging systems. The quality management of these devices involves rigorous regulatory standards to ensure safety and functionality. This includes compliance with international standards such as ISO 13485, which specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Application Areas

  • Risk Management: Implementing processes to identify, evaluate, and control risks associated with medical devices throughout their lifecycle.
  • Regulatory Compliance: Ensuring all medical devices meet strict standards set by regulatory agencies like the FDA (U.S. Food and Drug Administration) or the EMA (European Medicines Agency).
  • Process Validation: Verifying that manufacturing processes consistently produce outputs that meet predetermined quality requirements.
  • Continuous Improvement: Utilizing feedback loops, including audits and corrective and preventive actions (CAPA), to enhance product quality and manufacturing processes.



A "medical device" in the quality management context is critical for ensuring that healthcare products are both safe and effective for public use. Stringent regulatory standards and quality management systems like ISO 13485 play pivotal roles in sustaining high safety standards and fostering trust among healthcare providers and patients alike.


You have no rights to post comments

Related Articles

Versatility at■■■■■■■■■
Versatility in the industrial and manufacturing context refers to the ability of a product, system, or . . . Read More
Manufacturer at■■■■■■■■■
In the industrial or industry context, a manufacturer is an entity or company that produces finished . . . Read More
Patient at■■■■■■■■■
In the industrial and industry context, a patient refers to a specialized component, often in medical, . . . Read More
Alteration at■■■■■■■■
In an industrial context, alteration refers to the process of making changes or modifications to a product, . . . Read More
Course at■■■■■■■■
Course in the industrial and industry context typically refers to structured training programs or educational . . . Read More
FVT ■■■■■■■■
FVT may refer to Functional Verification Test or Field Vane Test or Final Verification TestingIn the . . . Read More
Device ■■■■■■■■
Introduction/DefinitionIn the context of quality management, a device refers to any tool, instrument, . . . Read More
Instrument ■■■■■■■■
Instrument in the quality management context refers to a tool, device, or mechanism used to measure, . . . Read More
Appliance ■■■■■■■■
Appliance in the context of quality management refers to any device or equipment designed for a specific . . . Read More
Magazine at■■■■■■■■
In the industrial and industry context, a magazine typically refers to a specialized container or storage . . . Read More