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Special Considerations during Medical Device Design: Dos and Don'ts Webinar  

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Online Compliance Panel

Special Considerations during Medical Device Design: Dos and Don'ts Webinar seminar agenda print utility

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Seminar Summary:

In the past, the designer was in charge of everything that could go wrong in the product performance. Today product's manufacturing processes, supply chain controls, and product users have become disengaged in many companies: therefore most design engineers are far removed from many things going wrong. (see full course description)

 

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Training Course Syllabus:


Special Considerations during Medical Device Design: Dos and Don'ts Webinar

Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Instructor: Dev Raheja

Description:


In the past, the designer was in charge of everything that could go wrong in the product performance. Today product´s manufacturing processes, supply chain controls, and product users have become disengaged in many companies: therefore most design engineers are far removed from many things going wrong. The most efficient way to prevent recalls is to identify as many potential problems as early as possible related to safety, reliability, durability, and efficacy using the best practices. This needs to be done before approving specifications.

Why Should you Attend:

No person can capture all the requirements not even a team of intelligent cross functional members. This webinar will discuss about the structured methods with which a company can capture most of the requirements. Insufficient knowledge will lead to insufficient device performance. Therefore entire product development team should take advantage of this webinar


Objectives of the Presentation:

Learning objectives of this webinar are:


  • Right things you must always do

  • Conducting Requirements Analysis to Identify Missing Requirements

  • Conducting Preliminary Hazard Analysis (PHA) to Assess Risks

  • Negative requirements Analysis for Worst Case Scenarios

  • Specification for Safety, Durability, and Reliability

  • Specification for User Interface and Usability

  • Specification for Maintainability

  • Designing for hazard-free maintenance

  • Specification for Prognostics

  • Specification for Safe Software

  • Mitigating risks using world class practices

  • Installation qualification, operational qualification

  • Performance qualification

  • Specification for Safety, Durability, and Reliability

  • Specification for User Interface and Usability

  • Designing to Forgive User Errors

  • Specification for Prognostics

  • Independent verification and validation

  • Wrong things you must avoid

  • Group Think process

  • Myopia of knowledge

  • Inefficient team management

  • Approving specifications without challenge

  • Mitigating risks using outdated practices

  • Accepting costly solutions

  • Insufficient control on residual risks

Seminar Summary:

In the past, the designer was in charge of everything that could go wrong in the product performance. Today product's manufacturing processes, supply chain controls, and product users have become disengaged in many companies: therefore most design engineers are far removed from many things going wrong. (see full course description)

 

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