The EU is conditionally extending the MDR deadline. If you are a medical device manufacturer with a certificate approved before 26 May 2021, you can extend its validity if your product meets the set conditions. One of these conditions is establishing an MDR-compliant...
According to EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 covering medical devices, manufacturers must demonstrate that the selected critical suppliers, contractors, and consultants meet all specified requirements, including quality requirements. These...
The FDA modernization act to end animal testing has now passed the US Senate. This change nullifies the old mandate requiring animal testing of all new drugs, thereby increasing the acceptance and use of Quantitative Structure-Activity Relationship (QSAR) and...
Are you a pharmaceutical manufacturer? Do you know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by the various regulatory agencies? SAXOCON has the expertise and services necessary to help you to...
We now offer access to the GARD® technology platform, a second generation of in vitro assays for skin sensitization testing based on genomics and machine learning. The GARD® technology platform, developed by SenzaGen AB, is intended to gradually replace all...
Complying with EU Medical Device Regulation (MDR) is not optional. If you are a manufacturer, authorised representative or distributor of medical devices, you will need to ensure compliance with EU MDR. Non-compliance with biological safety requirements can result in...
