Define your product boundary and responsibilities
A connected device rarely consists of a circuit board alone. Firmware, an application, a radio module and a backend may jointly enable a product function. Before planning measures, define the product boundary, how it is supplied to the market and the role of each company involved.
Define product scope and rolesConsider the device firmware and backend together
Assess direct and indirect data connections and components marketed separately. A backend may form part of the product as a remote data processing solution if it was developed under the manufacturer's responsibility and its absence would prevent the product from performing a function. Describing it as cloud-based does not settle the question.
The manufacturer is generally the party that develops a product, or has it developed, and markets it under its own name or trademark. A contract developer does not automatically assume that role. Importers, distributors and third parties making substantial modifications need separate consideration.
An IoT sensor example
An OEM markets a sensor under its own brand. A development partner supplies the firmware; a backend processes readings for an advertised alarm function. The assessment needs to cover the product boundary, including necessary backend functions, the OEM's role and the information the development partner must provide. This is an illustrative example.
What Solvetronix helps you establish
- A product and version overview covering hardware, firmware, applications and relevant backend functions.
- Documented role assessment and regulatory scope analysis by Solvetronix, with open questions identified.
- Technical interfaces and information required from suppliers.
Related topics
Legal basis and sources
General information and technical guidance. The specific assessment depends on the product, role and use. Reviewed 22 October 2026.