No Boundaries for MD Quality
MontJade Engineeringis a qualified medical device manufacturer. We follow international MDD and register ourselves in Taiwan, Japan, USA and EU government administrations. We handle not only medical device components and surgical kits but also medical sterilized/non-sterilized packs upon customers’ request. We could support technical documents for customers’ MD applications.
MontJade Engineering has ISO13485 quality system certified by DNV notified body. We could prepare design technical documents or we could support TFDA (Taiwan), CE Marking (EU) and/or FDA 510K (USA) applications of medical device products according to customers’ needs.