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Case Study.

RA activities for the worldwide registration of standalone software.

A client needed to ensure that the global registration of its standalone software (EU Classification IIb) was completed on time, taking into account specific regulatory requirements in different countries.

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The Challenge.

The company faced several challenges when registering its stand-alone software:

  • New software regulations in many countries: Many countries have recently introduced regulations for software registration.
  • Subsidiaries and dealers: Little experience with the new regulatory requirements poses challenges.
  • Long processing times at authorities and notified bodies (NB): Particularly in the EU, we are currently faced with longer processing times for registration.

The Benefits.

  • Close communication with notified bodies (NB) to clarify questions and respond quickly to requests for information.
  • Collaborate with Product Management (PM), regarding approval status, to set regulatory priorities and adjust strategies.
  • Coordination with Development (R&D) to clarify technical queries from authorities/designated bodies and update regulatory strategies, taking into account further product development.
  • Communication with the countries: Provision of country-specific documentation and support for individual requirements.

The Outcome.

Approvals in around 50 countries:

The company achieved approval in around 50 countries worldwide.

Finalized rollout:

Two software versions were successfully launched worldwide.

Shorter response times:

Thanks to efficient communication and shorter document creation times, long processing times have been minimized.

The Result.

Thanks to close cooperation between all parties involved - product management, development, country representatives and notified bodies/authorities - the company was able to accelerate the approval of its standalone software in around 50 countries and successfully launch the software worldwide.

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