Qlicksmart partners with or provides services to Australian companies looking to meet GMP, ISO 13485:2016 and other medical device regulations. Our technical team’s expertise is in translating existing manufacturing and quality assurance processes to meet medical device regulations with limited disruption and implementing medical device regulations including Australian TGA, FDA 21 CFR 80, and European MDD 93/42/EEC & MDR 2017/745.
Gap Analysis Audit and Review of Current Processes
Qualified auditors conduct on-site reviews of the company’s current quality management documentation to identify gaps in their process to meet medical device regulations and requirements for GMP compliance.
Gap Analysis Audit and Review of Current Processes
Qualified auditors conduct on-site reviews of the company’s current quality management documentation to identify gaps in their process to meet medical device regulations and requirements for GMP compliance.
Gap Analysis Audit and Review of Current Processes
Qualified auditors conduct on-site reviews of the company’s current quality management documentation to identify gaps in their process to meet medical device regulations and requirements for GMP compliance.
Gap Analysis Audit and Review of Current Processes
Qualified auditors conduct on-site reviews of the company’s current quality management documentation to identify gaps in their process to meet medical device regulations and requirements for GMP compliance.
Gap Analysis Audit and Review of Current Processes
Qualified auditors conduct on-site reviews of the company’s current quality management documentation to identify gaps in their process to meet medical device regulations and requirements for GMP compliance.
Gap Analysis Audit and Review of Current Processes
Qualified auditors conduct on-site reviews of the company’s current quality management documentation to identify gaps in their process to meet medical device regulations and requirements for GMP compliance.
Gap Analysis Audit and Review of Current Processes
Qualified auditors conduct on-site reviews of the company’s current quality management documentation to identify gaps in their process to meet medical device regulations and requirements for GMP compliance.
Gap Analysis Audit and Review of Current Processes
Qualified auditors conduct on-site reviews of the company’s current quality management documentation to identify gaps in their process to meet medical device regulations and requirements for GMP compliance.