The Situation

An emerging technology company had a software as a medical device product, that had gone through the initial research. However, the company was technology based and did not have a regulatory organisation to guide them.

The Solution

DQA senior personnel mentored the CEO in the quality and regulatory standards expected to emerge into the market. A full dissection was conducted of Industry Standards (ISO/IEC), Regulations (Global and Country Specific) and Guidance for submission of the device to key regulatory authority review departments.

Results

The company has now conducted its first submission and is awaiting positive regulatory opinion. The journey the company has taken has embedded quality into its systems and given global awareness of the place of IT quality within the organisation, and its importance now and in the future.

DQA Advantage

Understanding. Total and unequivocal understanding of the regulatory frameworks, and the ‘how to’ approach of implementation. Making the client a success as central to our customer focus ethos.