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Medical Device Software Lifecycle Processes

Picto Training Medical Device Software Lifecycle ProcessesCourse Objectives

  • Knowledge of the European regulatory requirements (Medical Directive 2007/47 / EEC) and US (FDA) related to the development and software validation.
  • Identify and understand normative documents or useful guides to claim conformance to regulatory requirements.
  • Know how to implement the quality management principles for the development of software medical devices.

Program

Day 1

  • Welcome and Introductions
  • The Regulation: the regulatory provisions relating to the development and software validation
  • Introduction to the US and European requirements
  • Introduction to standards and guides available to industry to address regulatory requirements
  • Planning software development
  • Defining Requirements (System Input Data)
  • Building & Design of software

Day 2

  • Implementation of a risk management process applied to software
  • Testing carried out on the software
  • Configuration and cyber Security management
  • Software Maintenance and resolution of software issues: how to apply a corrective and preventive actions process?
  • Course evaluation, synthesis and conclusions

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clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

Click here to Register


 

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

Click here to Register

Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager