Newel Health Achieves Triple Certification Milestone: Upholding Excellence in Healthcare Solutions



We are delighted to announce a significant accomplishment at Newel Health – the attainment of not just one, but three prestigious international certifications: ISO27001, ISO13485, and ISO9001. This important achievement underscores our unwavering commitment to excellence, integrity, and customer-centricity in the healthcare industry, and reflect the passion and dedication we put into the creation of our Digital Therapeutic (DTx) solutions. In this blog post, we will delve into the importance of these certifications and how they enhance the value that they bring to businesses partnering with Newel Health.

ISO27001: Safeguarding Data Security

Securing sensitive data is paramount in today’s digitally interconnected world. ISO27001, the Information Security Management System (ISMS) standard, validates that we have implemented stringent security practices to protect vital information, including personal health data and critical business records. With this certification, our partners and customers can rest assured that their data is shielded from unauthorized access, breaches, or potential threats. By prioritizing data security with its proprietary DTx software framework, H.Core, Newel Health establishes a foundation of trust and confidentiality, which is crucial for the success of any healthcare partnership.

ISO13485: Ensuring Quality in Medical Devices

For medical device manufacturers and providers, adhering to rigorous quality standards is of vital importance! ISO13485, the Quality Management System (QMS) standard designed specifically for the medical device industry, reinforces our commitment to delivering safe and reliable medical products and services. This certification exemplifies our compliance with regulatory requirements, industry best practices, and risk management protocols. At Newel Health, quality is at the core of everything we do, and ISO13485 certification highlights our dedication to maintaining the highest standards of quality throughout our operations.

ISO9001: A Commitment to Customer Satisfaction

In the competitive healthcare landscape, customer satisfaction is a key differentiator. ISO9001, the Quality Management System (QMS) standard applicable across all industries, provides a framework for Newel Health to continually improve and enhance our products and services. By following a systematic approach to quality management, we ensure that our customers receive consistent and exceptional experiences. This certification reinforces our pledge to put our clients at the center of our DTx Solutions, and listen to all our stakeholders’ needs to deliver solutions that exceed their expectations.

The Value of Doing Business with Newel Health:

Receiving ISO27001, ISO13485, and ISO9001 certifications cements Newel Health’s position as a trustworthy partner in the world of Digital Therapeutics.

Our healthcare sector partners and clients can expect the following benefits when collaborating with us:

  1. Unparalleled Data Security: We prioritize the confidentiality and security of sensitive information, ensuring our partners’ peace of mind.
  2. Uncompromising Quality: Our software medical devices (SaMD) and services undergo rigorous quality control measures, guaranteeing safe and reliable solutions for patients and healthcare providers.
  3. Customer-Centric Approach: We actively listen to our clients, continuously improve our offerings, and go the extra mile to ensure their utmost satisfaction.


At Newel Health, we are immensely proud of achieving ISO27001, ISO13485, and ISO9001 certifications, as they signify our commitment to excellence, quality, and data security. These certifications reinforce our position as a leading Digital Therapeutics player in the healthcare industry and provide added value to our clients, partners, and stakeholders. As we move forward, we will continue to innovate, grow, and uphold the highest standards in delivering cutting-edge DTx solutions.

Together, let us shape a healthier future where patient well-being and customer satisfaction remain at the core of everything we do.

PierPaolo Iagulli

PierPaolo Iagulli

Chief Operating Officer and Co-Founder at Newel Health in charge of operational excellence across the company’s multiple business units, from R&D to development and commercialization. Pier Paolo is a technology entrepreneur and web marketing expert passionate about Artificial Intelligence and the impact that new technologies will have on our lives and society.