At Systec Dizainas, we are always excited to work on innovative projects, and our recent collaboration with Pulsetto has been no exception. Here’s how we guided Pulsetto through the CE certification process for their health device, making sure it was safe, reliable, and ready for the market.

About Pulsetto

Pulsetto is all about improving lives through neuromodulation and wearable technology, such as their innovative, first hands-free vagus nerve stimulator. They are on a mission to help people manage stress, anxiety, sleep issues, and other chronic conditions with the latest advancements in neuromodulation. By combining science and technology, Pulsetto’s addresses common wellness challenges, enhancing mental well-being and overall quality of life. Their focus is on creating user-friendly solutions that help people feel better and lead healthier lives.

Addressing the Requirements

Pulsetto needed to ensure their wearable vagus nerve stimulator met European regulatory standards to earn the CE mark. The CE certification is important for electronic products entering the European market. It confirms that the product meets EU safety, health, and environmental regulations, ensuring its reliability and enhancing the company’s credibility.

Pulsetto had to follow the requirements of the Radio Equipment Directive (RED). As with all low power radio devices, the vagus nerve stimulator had to be tested for radio performance, electromagnetic compatibility (EMC), and overall safety evaluations. These tests were necessary to ensure the device wouldn’t interfere with other electronics, would operate safely in different conditions, and pose no risk to users.

Systec Dizainas Tailored Solutions

To tackle regulatory challenges, Pulsetto partnered with Systec Dizainas for complete CE certification services. Here’s how we made sure their vagus nerve stimulator met all necessary requirements:

1. Radio Performance Testing: For radio testing, we applied the EN 300 440 standard, which covers technical specifications for short-range devices operating between 1 GHz and 40 GHz. We tested the device’s frequency stability, output power, and spurious emissions. Passing these tests was a significant milestone, confirming the Pulsetto device operates safely within the assigned frequency range and does not interfere with other electronic devices.

2. Electromagnetic Compatibility (EMC) Testing: Using the EN 301 489 standard, we evaluated the device’s radiated emissions and its resistance to electromagnetic disturbances. The Pulsetto device met all the requirements, confirming its reliable performance in real world environments without causing or being affected by electromagnetic interference.

3. Safety Testing: We followed the EN 62368 standard to assess the device’s electrical safety, protection against electrical failures, fire resistance, and mechanical durability. The vagus nerve stimulator met all safety criteria, confirming that it’s safe for consumer use.

Key Benefits of CE Certification

Achieving CE certification brought Pulsetto several benefits for successful entry to the European market:

– Market Access: CE certification allowed Pulsetto’s health device to meet critical European distribution requirements, effectively opening doors to a wide and diverse market. Additionally, the CE mark establishes a foundation for growth by expanding the product’s market potential and creating new business opportunities.

– Credibility and Safety Assurance: By meeting the EU’s health, safety, and environmental standards, Pulsetto not only showcased their commitment to quality and safety but also enhanced its reputation. This certification ensures product credibility, building trust with customers and stakeholders.

– Competitive Advantage: The CE mark gave Pulsetto’s vagus nerve stimulator a competitive edge in the market by indicating high quality and regulatory compliance. This advantage can help the product stand out and establish a strong position against competitors.

We are proud to have supported Pulsetto in their mission to address health issues such as stress, anxiety, and sleep disorders. By working together for CE compliance testing, we ensured their device met all regulatory standards, resulting in a faster time-to-market, improved market positioning, and a reliable product ready for real-world use. We look forward to continuing our partnership and supporting future innovations in health technology.

At Systec Dizainas, we are dedicated to helping companies like Pulsetto navigate the complexities of regulatory compliance and bring their innovations to life. If you’re preparing for a product launch or certification, we’re here to help with expert pre-compliance and compliance testing to ensure your product meets all regulatory standards smoothly and efficiently.

Contact us to streamline your path to market readiness and drive your innovations forward!