Mediteq Svenkebo AB is a consultancy based in Göteborg that specializes in regulatory expertise for the medical technology sector. The company offers a range of services designed to support innovators and entrepreneurs throughout the product development process, from initial concept to market-ready products. A key focus of their work is assisting clients with CE marking, ensuring compliance with European regulations.
In addition to consulting services, Mediteq Svenkebo AB conducts workshops on biocompatibility theory and practice, providing valuable insights into the safety and effectiveness of medical devices. They also offer online training programs that cover the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), as well as training on quality systems in accordance with ISO 13485:2016. Internal audit training is also available for organizations involved in medical technology, helping them to maintain compliance and improve their operational processes.
The company actively engages with the medical technology community through forums focused on innovation and provides resources to aid compliance with medical device regulations. They also offer a newsletter subscription to keep stakeholders informed about updates and developments in the field.