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 involved in software standards development including IEC 62304, IEC 80002-1, Cybersecurity, IEC 60601-1 PEMS, UL 1998 & UL 5500, IEC 80001, and AAMI TIR45 and can train your staff in pragmatic and efficient methods of conformance to standards.

Our training can be tailored to your needs, your products, your regulatory perspective, and your business objectives. Our training includes FDA enforcement examples, key FDA guidance, electronic, checklists, and other educational aides. We provide real-life examples and help apply the standards in practical ways.

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