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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, The Netherlands. As
your Regulatory Authorized Representative, we provide
professional regulatory support for 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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