CE MARKING
In order to be able to sell a product on the European market, a medical device must comply with the various directives and regulations in force.
The rules 2017/745 on medical devices is the main regulation to follow, but others may also apply depending on the nature of the medical device.
For example, for electrical appliances, Directive 2014/30/EU on electromagnetic compatibility as well as Directive 2014/53/EU for radio equipment may apply.
QMS ISO 13485
The ISO 13485 standard defines the requirements for quality management systems for medical devices.
It allows the establishment of processes and documentation that will improve product quality and ensure that customer and regulatory requirements are met.
It is mandatory to have a QMS and be certified for any higher class of medical devices to class 1.
RISK MANAGEMENT ISO 14971
The ISO 14971 standard specifies the requirements for risk management related to medical devices.
This standard is fully integrated into a QMS which requires the implementation of a risk management strategy.
The risks of the medical device must be defined, evaluated and reduced to an acceptable level.
Reduced risks should also be monitored once the device is on the market.
SOFTWARE IEC 62304
The IEC 62304 standard defines software requirements for medical devices.
This standard applies for the entire life cycle of software.
It is a recognized standard in both the European Union and the United States.
The standard defines 3 classes of software according to its level of risk.
HARDWARE IEC 60601-1
The IEC 60601-1 standard defines the safety and performance criteria for electrical medical devices.
It takes into account the various dangers that can occur on a physical device.
This standard makes it possible to prove the conformity of medical devices with regard to the regulation on the devices medical.
USA MEDICAL DEVICES
Do you want to sell your medical device in the United States?
As in Europe and Switzerland, your medical device must comply with certain standards and regulations in addition to being registered with the authorities.
We are here to support you in all these steps to help you put your product on the American market.
A MEDICAL PROJECT?
Do you have a project in the medical field? Do not hesitate to contact us:
+41 79 737 37 93