Legal Manufacturer
Only a certified legal manufacturer can bring a software medical device to market. We are one.
Newel Health is a certified SaMD legal manufacturer, ISO 13485, MDR, and FDA-aligned, taking full regulatory responsibility for every product we build, from first design decision to post-market surveillance.
What this means
This isn't a title. It's an accountability.
In the world of Software as a Medical Device, a legal manufacturer is not simply the company that writes the code. It is the entity that takes full legal and regulatory responsibility for the device: its safety, its performance, its clinical claims, and its continued compliance throughout its entire lifecycle.
That means owning the Design History File. Conducting and documenting risk management under ISO 14971. Managing the clinical evaluation. Maintaining post-market surveillance. Reporting adverse events. Responding to regulatory queries. Handling field safety actions if something goes wrong.
Most software companies cannot do this. Most pharma companies do not want to build the infrastructure to do this for a software product. And most digital health startups have neither the certification nor the experience to take it on credibly.
Newel Health does. It is what we were built for.
Our certifications
These are not badges. They are the operational foundation of everything we build, and the basis on which regulators, partners, and patients can trust our products.
Why this matters for pharma
You don't need to become a device manufacturer. You need to partner with one.
For pharmaceutical companies and medtech organisations entering the digital therapeutic space, the legal manufacturer question is the one that determines whether a project reaches patients or stalls in a regulatory backlog.
Bringing a SaMD to market under EU MDR, FDA 510(k), or equivalent frameworks requires a certified manufacturer on record, an organisation with the quality management system, the technical documentation processes, and the regulatory relationships to carry the product through submission and beyond.
Building that capability internally is expensive, slow, and distracting. It takes years to establish an ISO 13485 certified QMS, hire the regulatory affairs team, and accumulate the documented track record that regulators look for.
Partnering with Newel Health gives you that infrastructure on day one, without the build time, without the overhead, and with the assurance that comes from working with a manufacturer that has already taken multiple products through certification.
Our regulatory infrastructure
ISO 13485 Certified QMS
Our Quality Management System is certified to ISO 13485, the global standard for medical device manufacturers. Every process, document, and design decision is governed by it.
IEC 62304 & IEC 62366 Software Development Lifecycle
We follow a fully compliant SDLC aligned with IEC 62304 (software lifecycle) and IEC 62366 (usability engineering), covering safety classification, architecture, verification, and human factors from first line of code.
Certification
We own and manage the full CE MDR certification process, including technical documentation, clinical evaluation, notified body audits, and declaration of conformity, taking the regulatory burden off our partners entirely.
Vigilance & Post-Market Surveillance
As the legal manufacturer of record, we run ongoing PMS and vigilance reporting, monitoring real-world performance, managing incident reports, and keeping every product compliant long after it reaches patients.
What we take responsibility for
From first concept to post-market. We own it.
Legal manufacturing is not a handoff at the point of submission. It is continuous accountability across the full product lifecycle.
Discovery & Feasibility
We engage early, evaluating the scalability and regulatory fit of a digital concept before major investment is committed. We provide technical due diligence and define the Target Product Profile with the commercial and clinical context in mind.
Design & Development
We lead system architecture, UX and human factors engineering, behavioral science integration, and software development, all within our certified QMS. We own the Design History File and Risk Management File from the first line of documentation.
Clinical Validation
We build trial-ready products. We align with GxP requirements, train clinical sites, and bridge the gap between digital technology and clinical trial operations. We support FDA and EMA interactions throughout.
Regulatory Submission
We prepare and own the technical documentation, including clinical evaluation reports, post-market surveillance plans, and Instructions for Use, and manage the submission process under MDR, FDA, or other applicable frameworks.
Commercialisation & Post-Market
We do not hand over the product at the point of certification and walk away. We remain the legal manufacturer through commercial deployment, managing post-market surveillance, vigilance reporting, field training, and lifecycle updates.
Bringing a software medical device to market demands more than innovation. It demands regulatory ownership, operational discipline, and the ability to execute with confidence. That is what a certified legal manufacturer makes possible.
Ready to move from concept to certified product?
Whether you are at the earliest stage of a digital therapeutic idea or approaching a regulatory submission with a product that needs a manufacturer of record, let's talk about what you are building and how we can help.