Aktiia Achieves ISO 13485 Certification

Aktiia Achieves ISO 13485 Certification

October 2019

This month we’re proud to announce that Aktiia has received the ISO 13485 certification, an important milestone in going to market with a medical device. ISO 13485 certification is the quality standard for companies who make the medical devices that we rely on every day, including everything from MRI machines to pacemakers to hip replacements.

The Aktiia product is designed as a sleek bracelet that fits into your everyday life, but it is not a lifestyle wearable. Hypertension is a medical condition, and we take our classification as a medical device very seriously. This certification helps clearly show the difference between Aktiia and consumer brands, almost none of whom are certified according to this standard. We are extremely proud of our Quality team and all employees across Switzerland, Serbia, and the USA for their focus on safety and quality first, allowing us to reach this milestone within just 18 months of our founding.

Our ISO 13485 Certificate from TÜV SUD

In this month’s survey, we’d love to learn a little bit more about hypertension affects you:

And thank you to everyone who completed last month’s survey. See the results below if you want to know what other subscribers find most interesting about the Aktiia product. (Note that the totals add up to more than 100% because it was multiple choice.)

  1. I’d like more frequent blood pressure measurements: 74.8%
  2. I’d like to see my nighttime blood pressure: 47.7%
  3. I’d like more accurate blood pressure measurements: 46.8%
  4. Blood pressure cuffs are painful to use: 16.2%
  5. Blood pressure cuffs are too loud: 12.6%

Several folks also wrote in that they are uncomfortable or feel that they get inaccurate readings from doctors or when taking their own measurements with cuffs, a very common phenomenon known as “white coat hypertension.” Thank you for your continued feedback, and we will keep working hard to bring our product to market so that you can accurately and comfortably measure your blood pressure throughout the day and night.