Webinar Series: 3DEXPERIENCE for global medical device development

Autumn 2016, tuesdays bi-weekly at 9:00 - 9:45 am CEST

Welcome to our webinar series about 3DEXPERIENCE for global medical device development – bridging innovation, quality and compliance.

Upon sign-up you will get access to all the live webinar sessions. You can then choose which ones you would like to attend. 

 

Session #1: Ease-of-use in Document Management  

Was broadcasted on September 13th

The benefits from replacing a paper-based documentation process with an EDMS are often well understood in the growing, global and regulated medical device organization. Additionally, the rationale of managing general document management with the same tools and practices as you have for managing product specifications and your design controls are becoming more widely accepted – especially with an increasing level of ease of use in the 3DEXPERIENCE platform.

 

Session #2: New device development, design controls and DHF  

Was broadcasted on September 27th

PLM implementations for device development can cover new product introduction from initial idea to regulatory release. The project deliverables are captured and agreed in a stage-gate process, and when they are tagged when completed the DHF is automatically generated. This session introduces the device product and how it is built up through the execution of the new device development project – and the single version of the truth of the device in the making.

 

Session #3: From complaints with DI, eMDRs and CAPA to effective change  

Was broadcasted on October 11th

Cross-functional change control of released devices is at the heart of the global medical device organization. The key to success is ease-of-use and visibility in the creation, definition and execution of changes on the device – reusing as much as possible of the DHF, QA history and existing sources, helping the user to filter out what is relevant – from all domains – engineering, manufacturing, sourcing, QA and RA - internal as well as external – in order to plan and execute efficient change orders, on mechanical, electronic, software related changes covering any aspect of engineering with impact on design controls, the DHF and DMR.

 

Session #4: Traceable requirements, risks control and prototype validation with CATIA 

Was broadcasted on October 25th

PLM enables an end-to-end process from identification of complaints to effective change. A process includes the following steps:

  1. Identify the complaint and initial trend for qualification
  2. Perform immediate actions for safety assessment, manage returns and initial analysis
  3. Prepare and submit potential adverse event report
  4. Determine need for and execution of CAPA including thorough root cause and risk analysis and trending – based on relevant device data sources –planned in co-ordination with ongoing development project and relevant change projects.
  5. Implementation of change on the relevant device level to prevent future non-conformances
  6. Confirm effectivity and close the CAPA and Complaint.

 

Session #5: Global market access - product compliance and regulatory submissions    

Was broadcasted on November 15th

All through new development projects and the device life cycle we track requirements and mitigate product risks. In this session we review how:

  • requirements are defined and detailed on the device product
  • hazards and risks are defined (according to ISO 14971)
  • risks control measures are documented
  • residual risk is tracked - in relation to design input and validation

The risks and requirements can be tracked either in the 3DEXPERIENCE platform or directly in CATIA – to place risk management in the hands of the design and manufacturing engineers who can build risk control intro their products and manufacturing processes.

 

Session #6: Global market access - materials compliance and supplier collaboration     

November 22nd - 09:00-09:45 CET

PLM is introduced in order to increase transparency between product management, product development and regulatory affairs – establishing one current and single version of the truth for global market access – building product compliance into the product portfolio and defining the control mechanism for the sales release in any country.

 

Session #7: Supplier Collaboration for bridging innovation, quality and compliance     

December 6th - 09:00-09:45 CET

The 3DEXPERIENCE platform is a key enabler for supplier collaboration, both in and outside the company firewall, allowing for different levels of collaboration and data exchange – from open innovation in early concept development to RFQ and change request negotiation to exchange of detailed product definition, specifications and product compliance evidence such as materials declarations or quality documents.

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Presenter: Petter Sahlin

Business Development Executive Life Sciences, TechniaTranscat

petter.sahlin@techniatranscat.com