Software as a Medical Device development.

ViewCo Digital is a Toronto-based Software as a Medical Device (SaMD) development partner. We provide a full product team or join yours, connecting software delivery with clinical integrations and release evidence.

Discuss your product

Work behind the service.

Selected contributions, with the scope made clear.

Clinical integration

Report delivery, verified in development.

We joined an existing team to build report submission, acceptance confirmation and a traceable delivery history, with eQMS release records.

Verified against a simulated EHR. Live patient-chart delivery is outside this account.

Explore the integration work

Mobile AI product delivery

From guided capture to a model result.

Product design and application engineering across iOS, Android and tablets, including AI integration, upload recovery and delivery support.

Our contribution covers the application. Clinical performance and clearance are separate.

Explore the mobile product work

Client work is described anonymously. References and further detail are available on request.

A full product team or expertise alongside yours

If you do not have engineers, we bring the product design, software and cloud capabilities needed for the agreed scope. If you already have a team, we can own a missing workstream and fit into your architecture, reviews and release process.

Your team provides business and clinical decisions. Together we establish who owns quality and regulatory approvals before implementation. We work with medical-device companies across Canada and the US.

What you receive at each stage

A first milestone worth building

We review the intended workflow, existing assets and uncertainties. The first scope defines what will be demonstrated, how it will be assessed and what remains outside the milestone. A proof of concept should help you make the next investment decision.

Software that fits its workflow

Delivery can include product and UX design, architecture, iOS and Android applications, web software and backend services. We integrate AI capabilities and handle the surrounding product states, including waiting, interruptions and recovery.

Cloud and healthcare integration can include AWS deployment and EHR/EMR connections. We agree what a successful handoff means and how the team will verify it.

A release your team can review and maintain

The agreed package can include reviewed implementation, verification results, deployment instructions and known issues. We support design reviews and eQMS release records, with approvals handled through your quality system.

What should a software handover make clear?

A handover should let your team review the release and continue the work. We agree the deliverables before building. Use these questions when reviewing a proposed scope:

  • Who owns the source code, and which repository, version and build are handed over?
  • What requirements and changes does the verification cover, and in which environment?
  • What remains unresolved, including limitations and known issues?
  • Who controls deployment access, configuration and recovery instructions?
  • Which design reviews and release records still need approval?
  • Who handles support and the next release, with what response expectations?

These are scoping questions, not a complete regulatory checklist. Our guide to software evidence and audit questions goes into the records. Ongoing support is scoped separately from the initial build.

Quality experience alongside engineering

Our team has participated in ISO 13485 audits for companies developing Class II and Class III software medical devices, answering auditors’ questions and providing evidence for our work. We have hands-on experience with Greenlight Guru and ins2outs, and completed basic awareness training in ISO 13485:2016 and ISO 14971:2019.

This describes our team’s experience and completed training, not company ISO certification. Regulatory strategy, clinical validation and submissions are led by your qualified specialists or separately scoped partners.

Planning your engagement

Can you develop our product if we do not have a software team?

Yes. We can provide the product design, engineering and cloud capabilities needed to start, then support delivery and evolution. We work with your subject-matter experts and establish who owns clinical, quality and regulatory decisions.

Can you work with our existing engineers?

Yes. We can take responsibility for a defined workstream, add a missing capability or join a wider product initiative. We agree interfaces, reviews and handover with your team so the work fits your existing product.

What determines the cost and timeline?

The product stage, supported platforms, integrations, testing scope and evidence requirements all matter. A focused proof of concept may take a few months; implementation and ongoing support can span years. We define the first useful milestone and estimate it with you before a larger commitment. Our SaMD development cost guide explains what changes an estimate.

Can you help with an AI-enabled medical product?

We can build the application, integrations and operational workflow around an AI capability. Intended use, model evaluation and clinical validation responsibilities need to be established with the appropriate specialists. Our AI development services also cover LLM features, agents and workflow automation.

What should we bring to the first conversation?

Your intended users, product stage, existing team and the next problem to solve are enough to start. If you have a prototype, requirements or a quality process already, we can use those to shape a practical scope.

Before choosing your development partner

Use our SaMD development partner checklist to compare scope, evidence and handover across proposals. If you are earlier in the process, start with the decisions to prepare before development.

A new product. A missing capability. A difficult next step. Let’s work out how we can help.

YOUR NEXT CHAPTER

What are you building?

Discuss your product with ViewCo Digital.info@viewcodigital.com