Webinar Series: Licensed to Cure for Medical Device Development

April 28, 2015

Licensed to Cure for Medical Device Development allows you to reduce time to market while meeting increasingly stringent and complex regulatory requirements. The essence is to establish one version of the truth for your complete and global device development organisation covering functionality such as:

  • Design controls - development project deliverables and resource management
  • Product definition and global change control – manage global development and product launch projects with change control for CAD, Parts and Assemblies, EBOM, MBOM, DMR, specifying documents, Design Controls, Technical File and QA processes.
  • Global market access – product and materials compliance management and status in ongoing product development
  • Requirements traceability – connect requirements to tests to prototype builds and products
  • Regulatory filing – create submissions such as 510k, technical file preparation and UDI connected to the development project deliverables
  • Quality assurance – connect Complaints, NCRs, CAPAs and Audits to the engineering changes and design controls.
  • Controlled documents – templates and approval workflows for documents and product definition, with SoP effectivity and training records.

The first session in the series introduces PLM for medical device development – answering the question how and why PLM bridges innovation and compliance.

The complete set of webinars:

Session 1: Bridging Innovation and Compliance - Licensed to Cure for Device Development

Nov 4. PLM defines one version of the truth for your product definition, compliance status and design controls. Instead of being reactive PLM allows you to proactively bridge innovation and compliance – building in compliance as part of your daily device development practice.

Session 2: Device Development Excellence - Design Controls in PLM

Nov 11. The key to excellence in device development is to implement efficient Design Controls. At any point in time you want to know the exact status of your project and program, what are the deliverables, what are the tasks, which resources are allocated, what are current bottlenecks and how are they resolved.

Session 3: QA in PLM – Complaints, CAPA, NCR, and Audits with Change

Nov 18. Quality practices can be efficient when the quality issues are visible to the team members who will resolve them – and all relevant information, full design controls with intention of use, risk analyses – the full IP - is available at the tip of their fingers. When integrated in PLM the quality processes are driven by the device development team and IP is built when the issues are resolved.

Session 4: Controlled Documents in PLM - Approval Templates, Effectivity for SoPs and Training

Nov 25. Efficient device development requires accurate Part 11 compliant document control and approval cycles connected with the product and their changes all through the device life cycle, and all through the implementation with training – in the same development backbone as the other product changes or your submissions and technical file.

Session 5: Regulatory Filing with UDI in PLM - The Bridge between Design Controls and Submissions

Jan 13. When creating and managing your Submissions (for example 510ks and CE-marking), DI and regulatory notifications in PLM, your Technical File, Dossier or UDI set (DI and GUDID interaction) are built and maintained as the deliverables of your development project. Additionally, regulatory reports such as your certificates and WEEE, REACh reports can be directly generated from PLM, securing data quality as well as transparency of compliance status for the complete enterprise. 

 

Session 6: Materials Compliance for RoHS, REACh & Conflict Minerals

Feb 3. EU-RoHS, EU REACh and Proposition 65 are going through rapid changes, and especially the ban and replacement of Phthalates in plastics is having an immediate impact on applications in device and diagnostics. This session covers why and how materials compliance processes are implemented in PLM, who is involved in this process and how it is applied in a typical device development organisation.

Session 7: Complaints Management and Adverse Events Reporting

Feb 17. Complaints management in PLM provides processes to capture and analyse incidents to determine reportability and trigger changes, and when reportable populate the relevant eMDRs or equivalent reporting directly from PLM. The trending connects complaints to related processes and data sources such as CAPAs, Design Controls, risks, risk mitigations and changes.

Session 8: Requirements Traceability - In full control - from device requirements to validation

Mar 17. Merging PLM with requirements and test management allows for full control from initial PRS to completed validation – of course supporting traceability, but more importantly laying the foundation for the compliance status for global market access, as well as confirming scope and an unbroken chain from requirements to risks to change to validation for prototype assessment.

Session 9: Design Controls - Project Excellence and DHF

Mar 31. PLM provides full control on project deliverables, resources and quality. In this session we cover how Licensed to Cure is used by the program management office to schedule tasks, qualify regulatory scope and strategy, review resource requirements for multi-site and cross-functional development, QA and RA projects.

Session 10: Global Change Control for Device Excellence

Apr 14. Global device development teams are using PLM to track status, execute changes and drive decisions across different time-zones and different continents. We will have a closer look at collaboration as part of product launch (CAD, BoM and DMR build-up) as well as product divestment activities.

Session 11: Quality Processes in PLM - Building in device quality in product development

Apr 28. Product quality is best managed closed to the IP. Through connecting quality processes with design controls and the product definition you establish one version of the truth for product development, projects and their compliance status. In this session we will follow a quality incident all through its CAPA, change and implementation.

 

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Petter Sahlin

Business Development Executive Life Sciences

+46 8 599 204 56

 petter.sahlin@techniatranscat.com

 LinkedIn Profile

PLM

PLM for Life Sciences

A need to rapidly introduce new products, research and documentation that require total traceability and patent applications that ideally should take less time – plus extremely hard regulatory demands. 

Learn more about PLM for Life Sciences