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Event info
Date:15 Apr
Time:12.00 - 17.00
Venue:Ørestad, Denmark

Building Compliance through Device Development Excellence

We are pleased to invite you to Medicon Valley Alliance’s Boost Seminar an introduction to ‘Product Lifecycle Management (PLM) for Device Development’ – covering key device development, QA, RA, sourcing processes  and how and why PLM is introduced to reduce leadtime in these processes.

Date: April 15, 2015
Time: 12.00 – 17.00
Venue: Edvard Thomsens Vej 14, DK-2300 Copenhagen S
Room: Oslo

Sign up here!

Program      

 12.00 Intro (while having lunch)
  Building Compliance through Device Development Excellence

The essence and what does PLM mean to the different roles in the device development organisation

Example Processes and Application Areas (Selected Live Demonstrations):

  • Ideation and concept development
  • Claims management
  • Modular management and variant configuration
  • Global product change and DMR management
  • Design controls, DHF, program and project management
  • CAD vaulting with Solidworks (or any other CAD)
  • Requirements to validation management
  • Systems engineering (RFLP)
  • Complaints to adverse events reporting to CAPA to Change
  • Controlled documents
  • Global market access – product compliance
  • Submissions, technical file/dossier and UDI
15:00 – 15:30 Coffee Break
15.30 – 17.00 PLM  – Implementation

  • Roadmap and Dependencies
  • Change Management
  • Validation
  • Fit with QSR, MDD and FDA requirements
17:00 End

 

Participation
For members: Free of charge (late cancellation*/no-show fee DKK 500 ex VAT)
For non-members: Free of charge (late cancellation*/no-show fee DKK 500 ex VAT)
(please see our event policy for non-members participation)

Registration ends on April 8th, 2015.
* If you cancel after the registration ends, it is considered late cancellation.

 

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