WISE COMPANY

We Provide the BEST solution, Way to enter new market

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Service

The services WISE COMPANY offers.

DEVICE CERT.

Europe, U.S.A, Korea DEVICE CERT.

ADMIN. SERVICE

Foreign Representative, Free Sales Cert, GMDN CODE, D-U-N-S Number, GUDID, E.U. Medical Device

QMS

ISO 13485, ISO 22716, cGMP, kGMP QMS

TECHN SPRT.

Technical Documents, Eng-Kor translation and interpretation, IEC 60601 Risk Management ···

Notice

The main news from WISE COMPANY.

We are experts in medical device and cosmetic certification processes of a lot of countries. Kinda sorry to say this but as all regulatory requirements get more and more strict, we are getting better and better with our skills, knowhow and income.

We founded our company at Apr. of 2016. I know you might think we are too young and inexperienced, and you may. We know and acknowledge there are a lot of experienced experts in the fields of medical device and cosmetic regulatory affairs.

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China is now looking inside to protect their domestic industries.
China is alredy closing their market for foreign companies in medical devices, cosmetics, electronics, and cultural industries.

Changes of certification and approval requirements of E.U. and U.S. has possibility to influence other countries because most of the coutries have adapted either European or U.S. system into their own.

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Medical device(hereinafter, CE MDD) certification in European counties is getting more and more difficult since 2013.

The European Commission has begun applying fourth amendment of Guideline for Clinical Evaluation (MEDDEV 2.7/1 Rev. 4) from June 2016, and another word for European medical device certification is clinical evaluation.

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› Check the Small and Medium Business Administration registration information

History

The history of WISE COMPANY.