With the increase of aging population over the years. Humans are more dependent on medical products as an answer to
their healthcare needs. As such, medical products supporting this sector need to be strictly certified prior being
placed into service.
Instrument, apparatus, appliance, material or software used on humans for the purpose of diagnosis, prevention,
monitoring, treatment or alleviation of disease, injury or handicap is required to undergo conformity to consumer
safety, health, and environmental standards when sold within EU market. It is mandatory for medical devices to be CE
marked, a conformity mark under the European Economic Area (EEA).
SPADE Consultancy is adept in this domain in which we offer our clienteles an extensive suite of services in which is a
rarity globally with consulting, testing and global certifications. Our extensive service list includes but not limited
to the below:
- Medical Device Certification (2007/47/EC)
- In Vitro Diagnostic Certification (98/79/EC)
- Quality Management System (ISO 13485)
- Personal Protective Equipment Directive (2016/425/EU)
- International approvals(ie. FDA, SFDA, KFDA, CMDCAS, TGA, PMDA etc)