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ISO 13485 - Certification

At Natural Cycles we have a quality management system. Natural Cycles is certified with EN ISO 13485:2012, the latest harmonized standard for medical devices. This means that every step of the product cycle is guided by processes which are consistent with state-of-the-art engineering and management processes, and ensures that you, the user, can benefit from the highest standards of quality and safety. Processes at Natural Cycles have been audited internally and externally.

We put YOU first in everything we do - from designing the app, implementing and testing it, marketing and supporting you as a user. We always think what is best for you.

The algorithm used in Natural Cycles has been clinically tested and research is performed on an on-going basis together with leading experts in the field of contraception and fertility. In a recent retrospective clinical trial, the application’s efficiency as a contraceptive method was challenged and 4054 women used the application as contraception for a total of 25 084 cyclesThe number of identified unplanned pregnancies were 143, resulting in a total pregnancy rate of 7.1 according to the Pearl Index. 10 of the pregnancies were due to the application falsely attributing a safe day within the fertile window, producing a perfect-use Pearl Index of 0.5. Calculating the cumulative pregnancy probability by life-table analysis resulted in a pregnancy rate of 7.5 %/year (95% CI; 5.9-9.1 %/year). This can be compared to the results of the 2011 study by J. Trussel, which indicates a method safety of 0.3 (slightly better than Natural Cycles) for the pill and a usage safety of 9 (worse than Natural Cycles). We don't stop here - we have several research projects and clinical studies on-going to further validate our results. 

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