SMEDTEC OS Product Roadmap

Product Roadmap

Built for what's next,
not just what's now.

SMEDTEC OS is the regulatory operations and intelligence platform for medical device teams. This roadmap sets out where the platform is heading — and what's already live today.

Document Ref

SMEDTEC-ROADMAP-001

Version

1.0

Last Updated

May 2026

Classification

Public

Multi-market regulatory operations Portfolio-relevant intelligence Market access & payer precedent Rep Hub — consultancy & statutory representation Per-organisation data isolation EU AI Act limited-risk posture

The platform develops across four areas. Each is in use today and deepens over time — what follows describes the direction of travel, with each step marked Next (in development) or Horizon (exploring).

Area 01

Regulatory operations

A single structured home for products, regulatory pathways and obligations across EU MDR, FDA 510(k), UKCA and EUDAMED — for in-house teams, for consultancies running many client portfolios, and (V16.0, May 2026) for firms holding formal statutory representation roles for non-domestic manufacturers: EU Authorised Representative, UK Responsible Person, US Agent and TGA Sponsor. Every engagement is tracked against its statute-cited obligations and the jurisdiction-specific identifiers and renewal deadlines it carries.

On the roadmap

Next Importer roles & vigilance case managementEU MDR Art. 13 importer obligations and a dedicated vigilance case object on top of the V16.0 deadline timers.
Horizon Broader jurisdiction coverageSwiss CH-REP, Health Canada Regulatory Correspondent and additional regional representation roles beyond the four shipped in V16.0.

Area 02

Regulatory intelligence

Recalls, safety notices, guidance and standards activity, filtered to the markets and device types in your portfolio rather than a generic feed.

On the roadmap

Next Standards lifecycle & transition exposureSee which active work depends on standards approaching revision — ahead of the deadline.
Next Portfolio-level surveillance awarenessDecision-support that surfaces relevant post-market activity around your devices.
Horizon Deeper portfolio intelligenceA connected view of each device's standing, and earlier sight of shifting classification.

Area 03

Market access

Reimbursement status tracked beside regulatory status, with searchable HTA and payer precedent for comparable devices.

On the roadmap

Next Evidence-gap insightSee the likely shape of the evidence bar — and where yours falls short — before commissioning a study.

Area 04

Trust & security

Security and data integrity are architectural properties of the platform — not features on a roadmap.

Every organisation's data is isolated at the database level, with encryption in transit and at rest, GDPR compliance, an audit trail on every data mutation, and an EU AI Act limited-risk posture.

On the roadmap

Next ISO 27001 certificationFormalising our information security management system toward certification.
Next Cyber Essentials certificationStrengthening the baseline controls behind the platform.
Horizon Cyber Essentials Plus & independent testingAudited certification and independent penetration testing as the platform matures.

Building the platform regulatory teams have been missing.

We work closely with early customers to shape what comes next. If that's a conversation you'd like to be part of, we'd be glad to talk.

Get in touch

This roadmap describes our current thinking and is shared to give a sense of direction. It is indicative, not a commitment: priorities and sequencing may change as we learn from the teams who use SMEDTEC OS. Certification statuses describe alignment and work in progress, not certifications held unless stated.