Special authorization from the BfArM for a Covid Test for self-testing

WQS receives a special approval for a Covid Test for Self-Testing under the approval number 5640-S-156/21

SARS-CoV-2 Antigen Rapid Test Kit

On April 7, 2021, WQS Management Consultant GmbH obtained special approval in accordance with §11 para. 1 of the Medical Devices Act. The announcement can be viewed at www.bfarm.de (5640-S-156/21).

Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.

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WQS Management Consultants Inc
136 4th Street north, Suite 201
St Petersburg, Florida 33701

Telefon: (925) 212-7683
Email: werner@us.wqs.de
Web: us.wqs.de

Special authorization from the BfArM for a Covid Test for self-testing

WQS receives a special approval for a Covid Test for Self-Testing under the approval number 5640-S-156/21

HOTLINKS

Contact

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