Legal Manufacturer of Software as a Medical Device
As a manufacturer of software as medical devices (SaMD), Newel Health is authorized to design, develop, and market digital medical devices that meet the same rigorous standards as physical medical devices. We ensure every product we launch meets global regulatory requirements for safety, performance, and clinical benefit.
Our commitment as manufacturers
Digital medical device manufacturing goes far beyond software development. It means taking full accountability for a medical devices’s lifecycle, from concept to clinical validation and post-market safety.
Maintaining traceability across design, development, verification, and validation
Conducting risk management and clinical evaluation under regulatory standards
Managing cybersecurity and post-market surveillance.
Ensuring products remain safe, effective, and compliant throughout their lifecycle.
De-Risking Digital Innovation Through Legal Manufacturing
For pharmaceutical companies and healthcare systems entering the digital health arena, partnering with a legal manufacturer eliminates one of the biggest barriers to scale: regulatory risk. Rather than building internal device infrastructure, partners can leverage Newel Health’s certified systems, technical documentation, and post-market processes to accelerate timelines and reduce cost.
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Regulatory Compliance
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Manufacturer Liability
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CE/FDA Readiness
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Market Trust
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Lifecycle Management
Legal Manufacturer
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ISO 13485 / MDR / FDA-aligned
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Newel Health assumes
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Established pathways
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Recognized by regulators
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Newel Health assumes
Legal Manufacturing as Your Competitive Edge
Credibility and compliance are the new differentiators in digital medical devices.
Partnering with Newel Health positions you ahead of the innovation curve, enabling impactful innovation, faster market entry and greater confidence from clinicians, payers,and patients.
"Only certified legal manufacturers can bring software-based medical devices to market. Partnering with one means you can do it faster, safer, and with full regulatory confidence."
Ervin Ukaj
CEO @ Newel Health