Two members of the Neotherix team have recently undertaken specialist medical device training in order to improve Neotherix' commercial readiness. The first three-day course described the most effective methods for planning and implementing a quality management system compliant with ISO 13485 (Medical devices - Quality management systems - requirements for regulatory purposes). The second two-day course covered the expert skills required to produce a comprehensive clinical evaluation report, in order to determine whether a clinical investigation is required or if sufficient data already exists.
The training, carried out by the international training and consultancy company NSF-DBA, will improve Neotherix' capability and places us in a stronger position to commercialise our products.
Link to the NSF-DBA web site .