Entries by Gustaf Ström

ISO 13485:2016 certification granted

The Quality Management System of Magle Chemoswed har been transformed from a traditional GMP system to a bilingual system also addressing the requirements of ISO 13485:2016 for Medical devices. After passing a successful onsite audit the ISO 13485 certification was granted on April 28, 2019 by the Notified Body CE Certiso, NB 2409. The scope […]

Planning permission granted

As a part of the efforts to modernize, Magle Chemoswed has invested in new modular facilites to be placed on the production facility site. We are happy to announce that planning permission has been granted by Malmö Stad and that our move from the Celsiusgatan facilites will move forward as planned. The new facliites mean […]

Advanced Wound Care products move forward

Magle Chemoswed has received positive responses from regulatory agencies for market authorization of its range of advanced wound care products. This provides us with a clear pathway to registration of these developed products. As a strategic market for the Company this is an exciting and welcome development. The first line of products are expected to filed […]

Benserazide provided to new key customer

Magle Chemoswed expands its sales of Benserazide to a key customer as part of the Company strategy to enter emerging markets. The sale of Benserazide is testament to our strong commitment to make a difference in the field of healthcare and responsibly expanding our business to new and exciting markets.

Patent for first-in-class surgical device filed

Magle Chemoswed has filed multi-jurisdictional patent applications for protection for our range of surgical diagnostic devices. This is a first-in-class invention under which we have chemically bound enzymatic indicators to our SmartSpheres to be used by surgeons following suturing to identify enzymatic leakage.