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Tue Feb 16
  • Seminar

Medical Device Software Demonstrating Compliance to IEC 62304 Seminar

  • Seminar

UL Provides Training on Medical Device Software to meet your needs:

Software has enabled increasingly advanced functionality and interaction in medical devices. Software driven user interfaces, stand-alone software applications, and mobile medical applications are becoming prevalent within the healthcare ecosystem. Software is increasingly relied upon for improving clinical efficiency and promoting improved patient outcomes. The IEC 62304 standard for medical Device Software – Software Life Cycle Process has been recognized by Multiple regulatory bodies as a standard by which medical Device Manufactures can support regulatory compliance claims. The IEC 62304 standard is also now a normative reference for embedded software in Medicals devices through the Amendment 1 of IEC 60601-1. This one day Training Session will provide the attendees with a study of requirements for Medical Device Software Lifecycle Process. They will present Examples to enable Software development organizations to assure documentation practice meet regulatory requirements, and will provide strategies on how to map your Organization’s current software lifecycle process to the requirements.

 

Topic

 

  • Introduction to software lifecycle process
  • An Overview of Regulatory recognition of the IEC 62304 Standard
  • An overview of the 5 key Process for software lifecycle described in the standard
  • An in depth examination of each clause in IEC 62304,

Focusing on 5 Key Processes

 

On Completion of this Courses you will

  • Have a working knowledge of requirements in IEC 62304
  • Have examples of how software development organization can meet the requirements
  • Know how to map your development process to the requirements of the standard

 

Who Should attend

  • Software developers
  • R&D Engineers
  • Product safety Engineers
  • Compliance Engineers
  • Product Designers
  • Technical Marketing Professionals

 

For more information or to register please contact Lavanya Pavan at [email protected] M: +91 96638 40174 T: +91 80 41384434

 

Venue: UL India Pvt Ltd.

Time: 9:00AM to 5:00PM

Cost:  Rs. 15,000.00/- + Service taxes

 

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