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 establish an 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 for Europe according to the guidelines of MDD 93/42/EEC and EN 46002.
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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