Start with the work you need someone to own
A team building its first medical software product has different needs from one adding an EHR integration to an established application. Before requesting proposals, describe the next product milestone and the capabilities you already have.
If you do not have an engineering team, ask who will lead product decisions, design the application and operate the delivery process. If you do, ask how the partner will fit into your architecture, reviews and release schedule. A list of available skills does not explain who takes responsibility for the outcome.
Our starting SaMD development guide can help you prepare that first brief.
Ask for a delivery walkthrough, not a logo slide
Choose a relevant example and ask the partner to explain its contribution. What existed before it joined? What did its team implement? In which environment was the result verified? What happened after handover?
A prototype, a development test and a production release establish different things. Ask the partner to keep those boundaries explicit. For an integration, sending a message is different from confirming that a receiving system accepted it.
In our clinical-report integration work, the recorded milestone was an automated development workflow verified against a simulated EHR. The useful evidence included submission, acceptance status and delivery history. It did not establish that a clinician had read a report in a live patient chart.
References can help corroborate the account. Where confidentiality limits public detail, ask what can be discussed privately without requesting another client’s records.
Check how engineering fits the quality system
Ask the delivery lead to walk through one software change from its requirement to review, verification and release. Find out which records the partner prepares, who reviews them and where they will live.
Experience using an eQMS is useful, but naming a tool is not enough. Ask how the records stay aligned with the implementation and how reviewer feedback is resolved. Our software evidence guide explains the practical questions.
Keep training, audit participation and organizational certification distinct when evaluating claims. Ask what was completed, whose system was audited and what the partner’s role actually was.
Name the clinical and regulatory owners
The proposal should identify who owns intended use, regulatory strategy, clinical validation and submission work, alongside engineering delivery. If a specialist is needed outside the proposed team, establish how that work will be scoped and coordinated.
Health Canada’s SaMD guidance explains that classification depends on the manufacturer’s labelled intended use and the applicable classification rules. A development supplier’s technology choices do not settle that question. Health Canada’s definition and classification guidance
Compare proposals on the same boundaries
A lower estimate may exclude the work another supplier includes. Ask each shortlisted team to state:
- The milestone and the evidence needed to accept it.
- Supported devices, platforms and integration environments.
- Assumptions about data, third-party access and your team’s availability.
- Included verification, release records and deployment work.
- How scope changes and unresolved issues will be handled.
- Ownership, repository access and the handover package.
- Support coverage after delivery and what it costs separately.
Our SaMD development cost guide shows why these boundaries change an estimate. For a difficult unknown, a focused first phase can be more useful than a detailed price for an untested assumption.
Take these questions to the first conversation
Ask who would lead your delivery and which comparable work they can discuss. Ask what they would investigate first, what could block the milestone and what they need from your team. Finally, ask what you would have in hand if the engagement ended after that phase.
Those answers should help you judge whether the team understands your product and can work with the people responsible for it.
At ViewCo Digital, we provide SaMD product development services as a full product team or alongside an existing one. Tell us about your next milestone and we can discuss the scope and responsibilities it needs.