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.
