On-Demand Webinar

Enhancing your medical device risk management

Everything you need to accelerate innovation in regulated industry

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This webinar will introduce the topic of Intelligent Design Control for use in Medical Device development with our solution Polarion ALM. To improve the maturity of your design control process, our proposal is to use a structured software-based system to enforce compliant data models and electronic workflows on all elements of the design control in order to assure accuracy of the design information and compliance with regulatory standards. In this way we will improve productivity, speed, and quality of the product development processes, leading to faster time to regulatory submission, approvals, and marketing/commercialization of new and changed devices.

What is driving our strategy?

Companies today rely on document management systems implemented in the last decade to piece together the evolution of their product innovation programs. They recognize that the need to refer back to their design controls is becoming more frequent and necessary as adverse events, recalls, and regulatory audits increase.

In addition, longer and more complex product timelines can face unexpected staffing changes, which can require new employees to review the design history to ensure project integrity.

Value Gained: Why participate in the webinar?

After attending this webinar, you will have a clear understanding what is possible in today’s Medical Device R&D, including:

  • Moving away from document-centric to a data-centric model of information

  • Multidisciplinary collaboration in design; Empowering mechanical, electrical, and software teams to author and manage design control information as linked data elements

  • Readily apparent regulatory compliance such as keeping the audit trail and electronic signature sign-off.

  • Re-use and parallel authoring of design controls on a user role-based concept with permissions and access rights

  • Final products that match their intended design, compile with a single technical documentation

Operational/regulatory topics of interest covered during the webinar:

  • IEC 62304 (Software life cycle processes)

  • ISO 14971 (Risk Management)

  • FDA 21 CFR Part 820 (CGMP)

  • FDA 21 CFR Part 11 (Electronic Documentation and Electronic Signatures)

  • Process and test data enforcement

  • Operational reports and dashboards

Meet the speakers

Siemens Digital Industries Software

Susan Faust

Product Account Development Specialist for ALM in Med-Tech & Pharma

Siemens Digital Industries Software

James Voller

Presales Solutions Consultant for Polarion