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Let Us Be Your Regulatory
Authorized Representative in Europe.
If you are a medical manufacturer
exporting your products to Europe under the
guidelines of the Medical Device Directive 93/42/EEC,
you are required to
have an established Regulatory Authorized Representative
in Europe.
Is your medical device company currently
exporting or planning to expand into the European Economic
Area (EEA)? The Medical Device Directive (MDD) requirements
are being more strongly enforced as part of new or renewing
CE mark audits.
The Regulatory Authorized European Representative
Program offered by Surgical Technologies, Inc., (STI)
provides complete support and compliance for your products
from our facility in Amsterdam. As
your Regulatory Authorized Representative, we provide
professional regulatory support of your products in
Europe, according to the guidelines of MDD 93/42/EEC
and EN 46002.
Backed by over 85 years of experience,
STI specializes in full-service medical device
contracting. Our Quality Assurance and Regulatory
Affairs systems are fully developed and provide
key insight for medical device manufacturers.
As experts in the medical device contracting and
manufacturing field, STI provides complete, confidential,
and thorough support for your company.
STI can facilitate your success in
the European Market.
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