Sci Doc Solutions provides gap analysis of current processes, performs independent audits on manufacturing facilities and processes within the biotech, pharmaceutical and medical device industries and provides regulatory assistance where required. We can assist in establishing quality management systems with all supporting documentation to ensure compliance.
Case Studies
Case Study 1: Sci Doc Solutions established a complete quality management system (ISO 13485) CE marking and Canadian Registration of the bell and pad alarm for treating bedwetting for Ramsey Coote Instruments
Case Study 2: Sci Doc Solutions provides Quality Assurance support for the manufacture of a Class 2a Sterile medical device for Livac Pty Ltd