Neola Medical AB (publ) today announces that the company has received certification of the quality management system according to ISO 13485, which is a critical step towards achieving CE marking and granted marketing authorization by FDA in the United States. An important milestone in the company’s commercialization plan has thus been achieved.
Neola Medical has undergone an extensive review process of its quality management system with an approved result, which means that the company has been certified according to ISO 13485. The certification shows that the company has a well-reviewed and comprehensive quality management system for the development, sale, and fulfillment of regulatory market requirements of medical technology equipment. It is an important milestone in the regulatory plan and a prerequisite for achieving CE marking and granted marketing authorization by FDA in the United States. The certification is carried out by BSI Group The Netherlands B.V., a leading internationally accredited certification body.
“We continue to show that we are achieving our set milestones according to plan. A certified quality management system is a prerequisite to sell medical devices internationally, and the certification means that we now have another cornerstone in place in our commercialization plan.”, says Hanna Sjöström, CEO at Neola Medical.
Read the entire translation of the Swedish press release here: Press communication
Read the press release (in Swedish) here: Press release