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Tequir's experience with healthcare regulatory procedures and management of quality systems based on the ISO 13485 norm, accredits it as a qualified assessor for companies who require expert and secure support with product regulation matters.   

The services Tequir offers in matter of medical device product regulation and quality systems are:

  • European Representative for international manufacturers who want to establish a commercial area in Europe.
  • Management of warning notes, field safety notices and vigilance procedures concerning medical device products in according the MEEDEV 2.12-1 guide.
  • Education in healthcare management by means of the following training courses: 
    • Medical device product regulation
    • Implementation of ISO 13485
  • Procedures and files for placing medical device products on the market.
  • Technical reports concerning the product.
  • Implementation of ISO 13485.
  • Performance of periodical audits and implementation audits.
  • Management of clinical trials and monitorization.
  • Preparation of a technical file concerning the products.
  • Management of knowhow protection.

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