We are pleased to share that a new edition of ISO 10993-1, the cornerstone standard for the biological evaluation of medical devices, has reached the Final Draft International Standard (FDIS) stage. This means the updated version — ISO/FDIS 10993-1:2025 — is now out...
From October 21–25, SAXOCON’s Chief Technical Officer, Carsten Baun Senholt, will participate in the ISO Technical Committee 194 (ISO TC 194) plenary meeting in Paris. Carsten is one of the many experts contributing to the scientific and technical collaboration...
Whether you are a pharmaceutical or medical device manufacturer, you need to comply with several layers of guidelines and regulations to bring your products to market and keep them there. Having suppliers you can trust is crucial to your ability to concentrate on...
Being part of a startup can be an exhilarating experience; working together to create new and exciting products, combining the talents and vision of your co-workers, and riding on the wave of enthusiasm make the blood, sweat, and tears worth it. But just when you...
According to EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 covering medical devices, manufacturers must demonstrate that their selected critical suppliers, contractors, and consultants meet all specified requirements, including quality requirements. These...
