Swiss Medic and digitalisation for Software Quality

von itsbusiness AG

Swissmedic, the Swiss Agency for Therapeutic Products, is involved in the entire life cycle of a medicinal products because of its mandated areas of responsibility in the sectors of licensing and the authorisation and monitoring of medicinal products. It is involved in the legal aspects of the process.

If you are involved in the development of software for medical devices or pharmaceuticals, you will have to work to the defined standards for your area. See our blogs on QA Standards for Medtech and GAMP5 on quality for pharmaceuticals.

Regulatory affairs departments suffer from problems:

  • Incomplete and inconsistent technical documentation.
  • Repetitive work like compiling the registration documents for the different markets.
  • Tedious coordination with the notified bodies, authorities and sending countless documents.
  • Requirements lack clarity.
  • Unacceptably long approval times.

Digitilisation is a key aspect of improving software quality and efficiency. The digital transformation helps you with:

  • Automation, reducing workloads considerably, saving on costs.
  • Approval, detecting documentation errors early in the process.
  • Makes regulatory affairs manager’s jobs easier.

We offer many services including a free Software Quality Health Check and also a more detailed Software Quality Audit to determine deficits in your SQA systems and provide concrete, focussed solutions to them.


itsbusiness AG, with more than 20 years’ experience delivering support for Software Quality is your reliable and trustworthy partner for digitalisation. We can help you with your concerns for the future and solve your Software Quality challenges.

If you have questions or need more information, please contact:

Andrew Connell
Software QA Expert, itsbusiness AG​

+41 79 843 58 52​


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