Complete set of documents supporting compliance with medical device regulations and clinical governance requirements. Includes SOPs and quality assurance guidelines.
Manufactured by
Regen Lab SA
Le Mont-Sur-Lausanne, Switzerland
Regen Lab s patented technology revolutionises blood component separation using thixotropic gel. Our kits undergo rigorous biocompatibility and safety testing, and are designed, manufactured, and packaged according to European and international standards. They meet the requirements of the European Medical Device Directive 93/42/EEC and the European Medical Device Regulation 2017/745. Regen Lab kits are CE certified and have clearance in multiple countries, including the USA, Canada, Australia, and China.
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