Goal/scope :

Good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of Medical Devices or Active Implantable Medical Devices.

Goal/scope :

Defines a series of requirements regarding the implementation of a quality management system in an organization, regardless of its size and sector of activity. It is part of the ISO 9000 series of standards.

Goal/scope :

Specifies the quality management system (QMS) requirements for regulatory purposes for the medical device industry.

Goal/scope :

Application of usability engineering to medical devices.

Objectif/scope :

Basic safety and essential performance of medical electrical equipment.

Goal/scope :

Dedicated to Medical Device Software – Software life cycle processes.

Goal/scope :

Application of risk management to medical devices.

Goal/scope :

Requirements for quality and competence applicable to medical biology laboratories.

Goal/scope :

Requirements necessary to ensure the quality of biological resources (for research, conservation of genetic heritage, education or economic valorization) – Certification of Biological Resource Centers.