Regulatory consulting service providing EU Authorized Representative support for medical device manufacturers. Assists with quality system certification, European regulatory compliance, and market authorization under EU Medical Device Regulations. Leverages specialized expertise in electronics-based...
Manufactured by
Gardien Limited
Dublin 2, Ireland
Gardien Limited is based in Ireland and provides high quality services as a EurEU Authorized Representative for the manufacturers of medical devices. Gardien Limited has extensive experience in European medical device industry in areas such as quality system certification, EU laws and regulations, marketing, business management consulting and more. The company has established a good working relationship with the State Pharmaceutical Regulatory Authorities, Chambers of Commerce, medical associations and certifying bodies throughout Europe. The company not only understands the situation of Chinese enterprises, but also is familiar with the thinking mode and regulatory priorities of various European medical departments, which can more effectively help domestic enterprises to enter the European market.
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