Compliance

LaproSurge ensures excellence through stringent and robust adherence to regulatory affairs and compliance. We implement a formal quality management system to satisfy the requirements of ISO 13485:2026 and are continually assessed and certified as meeting the requirements of ISO 9001:2015. All LaproSurge products meet the CE requirements of Directive 93/42/EEC Annex II and are free of latex and any other materials which are known to have biocompatibility problems. During the transition period, LaproSurge declare conformity with MDR and confirm MDD extension. We are also have a carbon reduction plan in place to improve our carbon footprint.