Medical Devices
A medical device is an instrument, apparatus, implement, machine, implant, in vitro reagent or other similar article which is intended for use in the diagnosis, prevention and treatment of disease or other medical conditions.There is a huge variety of medical devices, ranging from basic hand tools to complex computer controlled machines. These include simple devices like wound dressings and scalpels ; durable devices like wheelchairs and dentist chairs ; implantable devices like cardiac pacemakers and monitors, prosthetic limbs and prosthetic joints, life-supporting devices like respirators and lung ventilators; sophisticated, software-controlled devices like CT scanners and MRI machines.
Requirement for regulatory purposes is an internationally agreed standard that sets out the needs for a quality management system specific to the medical devices industry.It is designed for use of organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation, servicing and the provision of associated services.
Safety and performance of medical devices are paramount in this highly regulated industry; that is why quality management system is a regulatory or legal requirement in many countries.
Demonstrate compliance with regulatory and legal requirements;
Managing risk effectively
Improving processes and efficiencies
Gaining competitive advantage
Safety and performance of medical devices are paramount in this highly regulated industry; that is why quality management system is a regulatory or legal requirement in many countries.