Achieving IEC 62304 and FDA compliance

By TahaB

In the highly regulated world of connected care, compliance with international standards such as IEC 62304 and ISO 14971 is paramount. To meet these stringent requirements while maintaining flexibility, Polarion offers a powerful and customizable platform tailored to the needs of medical product developers.

Polarion understands the unique challenges faced by healthcare technology innovators and medical device manufacturers. That’s why we provide a preconfigured templates designed to address the specific demands of IEC 62304 compliance. With Polarion MedPack, you’ll have peace of mind knowing that these critical standards are fully covered.

Polarion MedPack supports you to do that in many ways by providing:

  • Additional Work Item types with specific attributes that cover all documentation requirements
  • Specific link roles between Work Items to fulfill IEC 62304’s strict traceability requirements
  • Traceability analysis support to detect broken traceability before the auditor finds it
  • Specific workflows for each work item type to fulfill verification and evaluation requirements
  • A role concept to fulfill the demand for in dependency between coder and tester or creator and reviewer
  • A lot of wiki pages for different views onto your project

Among the wiki pages you’ll find:

  • A topic-based view with interactive links to traceability analyses of
    • Requirements
    • Risk management
    • Product architecture
    • Testing
    • Feedback and problem resolution
    • etc…
  • A developer view that focuses on things to be done
  • A management view that shows the project’s progress
  • A notified body view which groups Work Items together in packages the auditor wants to see
    • Software development plan
    • Sofware integration plan
    • Risk management plan

In the Connected Care, risk management is non-negotiable. With Polarion RiskPack you integrate your risk management according to ISO 14971 directly into Polarion. It supports you in all phases of the risk management process and creates all necessary documentation. Along with this, you can benefit from all of Polarion’s advantages, meaning that …

  • You manage all your information within your familiar tool, so you don’t waste time with learning to deal with yet another one.
  • You need to enter all information only once, even if you need it at several locations. That saves time and reduces contradictions within your documentation.
  • You can adapt your risk management precisely to your situation and needs. You only do the amount of work necessary for an efficient risk management.
  • You know at one glance how complete your risk management documentation is. That prevents you from overlooking something important.
  • You can create audit proof documentation with a single click, without having to check references manually for hours.

Key Benefits of Polarion for Connected Care

  1. Streamlined Compliance: Reduce the effort required for customization and audit preparation to achieve compliance with IEC 62304, ISO 14971, FDA regulations, and more.
  2. Out-of-the-Box Knowledge: Polarion’s preconfigured template brings domain knowledge right to your fingertips, accelerating project rollout and reducing the learning curve.
  3. Efficiency and Speed: Implement Agile practices within a compliant framework to boost efficiency and reduce time to market while upholding the highest quality standards.
  4. Flexibility: Customize projects, artifacts, and workflows to align with your internal processes and meet external regulatory requirements without sacrificing flexibility.

Polarion is your dedicated partner in healthcare IT and medical device software development. By leveraging our customizable platform and preconfigured medical templates, you can confidently navigate the complex landscape of compliance, reduce development time, and bring life-saving innovations to market faster.

To learn more about how Polarion X keeps your Software Lifecycle Under Control in the Cloud, and how it can revolutionize your Connected Care product development, click here or better yet Test Drive Polarion Today!

Leave a Reply

This article first appeared on the Siemens Digital Industries Software blog at