Quality Policy

Our Mission

Newel researches, designs, develops, and provides digital medicine and digital therapeutics solutions.

Our Commitment

Newel is committed to ensuring that everything we do meets the explicit and implicit needs of our customers, patients, and users, with an approach that favors preventing problems over correcting them, and a continuous focus on innovation and improvement. Above all, we are committed to ensuring that the quality of the medical devices we design safeguards the safety of the people who use them.

To deliver on this commitment, Newel has implemented and maintains an Integrated Management System (IMS), certified to ISO 9001:2015, ISO 13485:2016, and ISO/IEC 27001:2022, bringing quality, medical device safety, and information security together under a single, unified approach. We design, develop, and place our products on the market in compliance with the EU Medical Device Regulation (EU) 2017/745 and other applicable medical device and digital health regulations in the markets where we operate.

Our Objectives

Through this Integrated Management System, and informed by ongoing analysis of our business context and of relevant risks and opportunities, Newel pursues the following objectives:

• Maintain an Integrated Management System certified to ISO 9001:2015, ISO 13485:2016, and ISO/IEC 27001:2022
• Meet customer needs and expectations at all times
• Ensure the safety of the people who use our solutions
• Comply with all applicable regulations, particularly those governing medical devices
• Invest in the continuous, effective training of our people
• Sustain and grow our position in the market
• Continuously improve the efficiency and effectiveness of our business processes
• Apply increasingly rigorous control over our production processes
• Set, implement, and review specific improvement objectives for our Integrated Management System on a regular basis

Management's Commitment

Newel's management is personally committed to:

• Supporting and implementing this policy
• Ensuring this policy is communicated, understood, and put into practice across the organization
• Fostering the training and development of our people
• Providing the resources necessary to implement and maintain our Integrated Management System
• Reviewing this policy at least annually to ensure it remains consistent with our mission