SoftwareCPR is planning a series of training courses in Kuala Lumpur, Malaysia (for Malaysian citizens). Our instructors understand regulatory agency expectations, including US FDA and EU,  and can train your staff accordingly and coach them on how best to articulate and defend your approaches in FDA and international standards terminologies. Our instructors have been in...Read More

Our ISO 13485 Internal Audit Training Course focuses on both the requirements of ISO 13485:2016 and the audit process and methods (ISO 19011) to ensure the manufacturer or supplier is compliant with the requirements of the standard. Our approach is to educate on the intent and purpose of the standard so that the participants are able...Read More

We understand the tension. You get it … we all want to be process focused. Create and maintain a good process, and good outputs will come forth. But you may be the one that faces the auditor or faces the inspector. They ask for evidence that the process was performed. You think, “life would be...Read More

The international standard, ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, provides the framework of the set of interrelated processes that work to ensure product quality.  This international standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be...Read More