GQS has been in the forefront in helping medical equipments to achieve the coveted ISO 13485 Certification. Medical products under Class 1, Class 2, Class 3 whose details are mentioned here below indicate the risk factors involved in usage or installation.
Class I Devices
Class I devices are considered to be at the lowest level of risk of all medical devices and are therefore required to comply with the lowest level of regulatory control. Examples of Class I devices include: elastic bandages, dental floss and enemas.
Class II Devices
Class II devices are simple devices, though they are more complicated than Class I devices. They are also considered to be at slightly higher risk than Class I devices and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety. Examples of Class II devices include: condoms, pregnancy testing kits and powered wheelchairs.
Class III Devices
Class III devices are generally considered to be the most complex devices. They are also considered to be at the highest risk and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety. Examples of Class III devices include: implantable pacemakers and breast implants.
Depending upon the Class of devices, GQS Singapore supports in
- Gap analysis based on ISO 13485 Certification
- Support in Classification of medical equipments
- Identification of relevant regulatory requirements
- Support in compliance to Regulatory requirements.
- Preparation of Medical equipment file
- Knowledge transfer of Contamination control
- Risk assessment
- Process and Design validation
- Product cleanliness
- Installation process
- Service process and many more required by the ISO 13485 Certification requirements.