Templates Setup & templates included. Fixed price. Class A / B / C.
FDA’s QMSR aligns with ISO 13485, replacing Design Controls with the Design & Development File. Most SaMD teams lack the structure for IEC 62304 and IEC 81001-5-1 compliance. This accelerator provides pre-validated templates ready to fill.
What teams are missing without this service:
No Software Development Plan aligned to IEC 62304 SW class
No D&D File structure meeting FDA QMSR / ISO 13485 §7.3
Cybersecurity documentation gaps (IEC 81001-5-1 / MDCG 2019-16)
Templates created ad-hoc — inconsistent, non-reusable, non-compliant
What's included — pre-validated template packages by software class
These are empty, pre-validated templates, not completed documents. Each is pre-formatted, correctly titled, and structured to meet the referenced standard. Your team adds the content. Documentation preparation is a separate service.
Class A Package
Low Risk SaMD /
Software Development Plan(SDP)
Software Requirements Specification (SRS) Framework
Access Control Policy
Configuration Management Layout
STRIDE Threat Modelling Document Matrix
Security Requirements Log
SBOM Automation Layout
Full IEC 62304 Class A lifecycle structure + complete IEC 81001-5-1 cybersecurity suite
Class B Package
Medium Risk SaMD /
All Class A template
Software Architecture Layout
V&V; Test Plan
System Test Protocols
Bug / Anomaly Log
Cumulative: includes all Class Assets. Adds architecture, V&V; and anomaly tracking.
Automated Unit Testing & Code Coverage Frameworks
Post-Market Vulnerability Management Plan Layout
Integration Tests
Class C Package
High Risk SaMD /
All Class B templates
Detailed Subunit Design Layouts
Code Verification Checklists
Cumulative: includes all Class B assets. Adds subunit design, code verification and post-market plan.
What you receive
What is in scope
Design and Development File structure setup (aligned to ISO 13485 §7.3 / FDA QMSR)
IEC 62304 software lifecycle document templates (class-appropriate)
IEC 81001-5-1 cybersecurity documentation templates
Traceability matrix layout between D&D; file sections
Naming conventions, document numbering, and folder structure recommendations
One 30-min handover session: walkthrough of all templates with your team
What is out of scope
Filling in the templates (document preparation) — offered as a separate service
Gap analysis or compliance assessment — covered by Audit Readiness Sprint
Regulatory submission or notified body liaison
Training your team on IEC 62304 or IEC 81001-5-1 — available as add-on
We need 30 minutes to explore how to accelerate your project.
Lock in your assessment.
Fixed-price packages
Software Class A Low Risk SaMD
€9,900/ Standard Price
€7,920
Included Scope & Deliverables
SDP
SRS Framework
Bundle Package
Access Control Policy
Config Mgmt Layout
STRIDE Threat Modelling
Security Requirements Log
SBOM Layout
Software Class B Medium Risk SaMD
€17,900/ Standard price
€14,320
Included Scope & Deliverables
All Class A templates
Software Architecture
Layout
V&V; Test Plan
System Test Protocols
Bug/Anomaly Log
Unit Testing & Coverage
Integration Tests
Software Class C High Risk SaMD
€19,900/ Standard price
€15,920
Included Scope & Deliverables
All Class B templates
Subunit Design Layouts
Code Verification Checklists
Unit Testing & Coverage
Frameworks
Post-Market VMPL
Engagement details
Typical timeline
Kick-off, scope confirmation, D&D; file structure design
Template build — IEC 62304 lifecycle documents
Template build — IEC 81001-5-1 cybersecurity suite
QA review, handover session, folder structure delivery
Who this is for
SaMD teams starting a new regulated development programme
Companies preparing for first MDR CE mark or FDA 510(k)
Engineering teams that need IEC 62304 compliance from sprint 1
Startups building connected /IoMT devices (IEC 81001-5-1)
Companies adopting FDA QMSR — updating Design Control artefacts
Terms
All prices are fixed fees excluding VAT.
Every engagement includes:
30-min discovery call
Written scope
Senior QA/RA review
Our Partners
