Connect product requirements, risks, controls, evidence, and design assurance
From design change to evidence-backed compliance readiness.
STREAM® Cloud helps medical device quality, regulatory, design assurance and product teams connect product requirements, design inputs, risks, controls, verification evidence, design reviews, change impacts, CAPA, post-market signals and readiness updates in one configurable workspace.
The product compliance and design assurance challenge
Design inputs, design outputs, design reviews and evidence often sit in different places. Product requirements, hazards, harms, risk controls, verification and validation evidence are not always consistently connected, and product compliance gaps are often found late — after design decisions have progressed.
Risk files can drift as design, supplier or post-market information changes. Audit, inspection, submission and certification evidence is frequently assembled by hand. Design changes can ripple into requirements, risks, supplier evidence, V&V and technical documentation — and supplier qualification, transfer and manufacturing evidence may not be connected to product compliance readiness.
Complaints, CAPA and PMS / PMCF / PMPF outputs do not always feed cleanly back into product risk and documentation, and leaders may see status summaries without the evidence chain behind them. Quality, regulatory and design assurance teams need a practical place to connect requirements, risks, controls, evidence, design reviews, change impacts and readiness — without starting from a blank page each cycle.
What evidence-backed product compliance and design assurance looks like
Moving from scattered requirements, risk files and V&V evidence to evidence- backed product lifecycle assurance is about traceability, action follow-through, evidence sufficiency and a current view leaders can trust.
Requirements, risks and controls connected
Product requirements, design inputs and outputs, hazards, harms, risk controls and residual risk held as linked records rather than parallel spreadsheets.
Verification and validation evidence
V&V evidence captured against the requirements, risks and design outputs it supports — with visible evidence status and sufficiency.
Design reviews with traceable actions
Design review outcomes, decisions and actions tracked through to closure, with the underlying evidence available behind each entry.
Change impact assessment
When a design, supplier or post-market input changes, the requirements, risks, controls and V&V evidence it touches are visible in one place.
CAPA, complaints and PMS feedback
CAPA actions, complaint trends and PMS / PMCF / PMPF outputs feed back into the risk file and product documentation rather than sitting in isolation.
Supplier quality linked to product compliance
Supplier qualification, transfer and manufacturing evidence connect to the product compliance and release readiness they support.
Release and inspection readiness
Release readiness, audit and inspection readiness views show what is in place, what is open and what is on the critical path.
Leadership assurance with evidence behind it
Concise readiness views for quality, regulatory and product leadership — with the evidence chain available behind the summary.
How STREAM® Cloud helps
STREAM® Cloud gives quality, regulatory and design assurance teams practical structure for the work behind product compliance — structured records, linked registers, dashboards and an audit history of what has changed. It supports ISO 13485 and ISO 14971 risk and design work, FDA Quality Management System Regulation (QMSR) readiness — which has incorporated ISO 13485:2016 by reference since February 2026 — and MDR / IVDR readiness work, without replacing the systems that already hold design, document and regulatory content.
Configurable record types for product requirements, design inputs and outputs, hazards, harms, risk controls, V&V evidence, design reviews, change requests, CAPA, complaints and PMS / PMCF / PMPF outputs
Configurable fields, with mandatory fields where required, so each register captures what your quality, regulatory and design assurance teams actually need
Linked records that connect requirements to risks, risks to controls, controls to V&V evidence, and design changes to the artefacts they affect
Search across structured data so teams can find the right requirement, risk, control, evidence item or action quickly
Dashboards and reports that update as data is entered, giving quality, regulatory and product leaders a current view of release, audit and inspection readiness
Exports for design reviews, technical documentation packs, audit and inspection support, and leadership updates
Permissions and controlled visibility so quality, regulatory, design, R&D, supplier quality and PMS teams see what is relevant to them
Audit history of changes to support oversight, scrutiny and design control discipline
Action tracking with owners, due dates, status, blockers and evidence trails for CAPA, design review actions and change impact follow-through
A guided product walkthrough so teams can see how the model fits their product lifecycle assurance approach
STREAM® Cloud works alongside QMS, PLM, eDMS, regulatory, engineering and clinical-evidence systems as a configurable assurance, evidence and follow-through workspace. Evidence can be stored or referenced, depending on implementation.
Quality, regulatory, design assurance and product teams in medical device and MedTech organisations
- Head / Director of Quality and Regulatory Affairs
- QA / RA Manager
- Design Assurance Lead
- Quality Director
- Regulatory Affairs Manager
- R&D / Engineering Manager
- Manufacturing / Supplier Quality Lead
- PMS / Vigilance / CAPA Lead
Teams responsible for product compliance, design assurance, risk file integrity, V&V evidence, design reviews, CAPA, supplier quality, PMS feedback and release, audit and inspection readiness across the product lifecycle.
When STREAM® Classic may be needed
STREAM® Cloud is the right starting point for most medical device quality and design assurance teams. Some organisations later need capabilities that sit in STREAM® Classic.
STREAM® Classic is the pathway for:
- Configurable automations
- Messaging and alerting
- APIs
- Advanced modelling
- Quantitative analysis
- Complex data sets
- Enterprise-scale cyber GRC
Foundation
Built on STREAM® Cloud
Structured records, configurable record types and fields, registers, linked records, search, dashboards, exports, permissions, audit history, action tracking, evidence and controlled visibility — the foundations medical device teams need to connect requirements, risks, controls, evidence and design assurance.
See how STREAM® Cloud supports medical device product compliance
Walk through how your team could connect requirements, risks, controls, evidence, design reviews and change impacts in one configurable workspace.