Medical device regulations

The set of national and international regulations with regards to the manufacture, safety, and distribution of medical devices.

rules covering medical devices
regulations concerning medical devices
legislation covering medical devices
regulations regarding medical devices
regulations controlling medical devices
international medical device regulations
national medical device regulations
laws covering medical devices

knowledge

cross-sector

Medical device regulations is an essential knowledge of the following occupations:

Medical device engineer: Medical device engineers design and develop medical-technical systems, installations, and equipment such as pacemakers, MRI scanners, and X-ray machines. They monitor the whole manufacturing process from concept design to product implementation. activities undertaken include, among others, designing product improvements, developing methods and techniques to evaluate design suitability, coordinating initial production, developing test procedures, and designing manufacturing diagrams.
Dental instrument assembler: Dental instrument assemblers assemble various dental instruments, such as drills, lasers, probes, mirrors, and dental imaging devices. They use various machinery, hand tools, chemicals, adhesives and epoxies to assemble the dental instruments. They use precision tools and work in cleanroom environments.
Medical device engineering technician: Medical device engineering technicians collaborate with medical device engineers in the design, development and production of medical-technical systems, installations, and equipment such as pacemakers, MRI machines, and X-ray devices. They build, install, inspect, modify, repair, calibrate, and maintain medical-technical equipment and support systems. Medical device engineering technicians  are responsible for the operational readiness, safe use, economic operation and the appropriate procurement of medical equipment and facilities in hospitals.

Medical device regulations is optional for these occupations. This means knowing this knowledge may be an asset for career advancement if you are in one of these occupations.

Mechanical engineer: Mechanical engineers research, plan and design mechanical products and systems and supervise the fabrication, operation, application, installation and repair of systems and products. They research and analyse data.

References

1. Medical device regulations – ESCO