Assessment Service for Medical Device Product Regulation

Assessment Service for Medical Device Product Regulation

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.