SxMD Templates

Top benefits of SxMD Templates

Revolutionize how you approach the development and compliance of medical software. From ensuring adherence to the stringent regulatory standards of the EU and US to significantly enhancing operational efficiencies, this module stands as a testament to innovation. Discover the transformative benefits that empower organizations to not only meet but exceed the benchmarks of quality, compliance, and speed in the software as/in a Medical Device industry.

SxMD compliant templates
Audit-ready flexible templates compliant with EU and US standards.
Integrated with infrastructure
Dynamically pulls data from Matrix into the templates with full traceability to all the standards that govern them.
Significant time savings
Speed up implementation and stand up your infrastructure up to 6+ months faster.
Clarity on best practices
Off-the-shelf structured eQMS with everything you need including instructions for each template.

Key features

The SxMD Templates are based on best practices as outlined by the International Medical Device Regulators Forum (IMDRF) for software development and include everything you need to develop software as/in a Medical Device compliantly including SOPs, work instructions, and document templates which help you comply with ISO 13485, ISO 14155, ISO 14971, 21 CFR 820, IEC 62304, and IEC 62366.

QMSA systematic approach to the quality management process to ensure product quality and safety.
ALMA framework for compliant and scalable development and technical documentation.
OQAEstablished structure to support the generation of all the Operational Quality Assurance (OQA) records as required by the regulations.
Tools validation packageFull validation of our SxMD solution and an extensible package to help you structure all your other GxP tool validations as required by the regulations.
HRA base structure to document employee information that can be used to ensure employees have the necessary qualifications and training to perform their roles in accordance with quality standards.
Custom PRINTA dedicated structure of print layouts for the ALM project.

Popular use cases

Whether navigating the stringent regulatory environments of global markets, pivoting from traditional hardware to software-centric models, or seeking to modernize and streamline legacy systems, the SxMD Templates addon emerges as a key enabler for success. Let's explore some compelling reasons that make this module a game-changer for businesses at different stages of their software as a Medical Device (SaMD), software in a Medical Device (SiMD) journey.

  • Companies developing for EU and/or US markets.

  • Companies new to the Software as/in a Medical Device industry.

  • Companies transitioning from hardware to software.

  • Companies adding software to a product.

  • Companies transitioning from paper, DIY, or other platform that don’t want to start from scratch.

Current templates

The SxMD Templates are updated based on major regulatory requirement changes and will continue to grow to include more valuable templates to support the needs of the MedTech industry.

Planning templates

  • Software design, development, and quality plan.

  • Software risk management plan

  • Software verification and validation plan

  • Post-market clinical follow-up plan

  • Post-market surveillance plan

Design Input templates

  • Software safety classification

  • User needs

  • Device hazard analysis

  • Risk analysis

  • Product requirements

  • General safety and performance requirement checklist

Design Output templates

  • System Architecture and Design Specification

  • Cybersecurity Risk Assessment

  • Instructions for use

  • Deployment specification/verification

  • Software FMEA

  • User FMEA

  • Formative Usability Study Protocol(s)

  • Formative Usability Study Report(s)

  • Verification test protocol

  • Validation test protocol

  • Tools validation package

  • Penetration testing

  • Software trace matrix

Design Review templates

  • Design review minutes - planning and design input

  • Design review minutes - verification readiness

  • Design review minutes - launch readiness

Design Verification & Validation templates

  • System verification and validation report

  • Risk management report

  • Summative usability study protocol

  • Summative usability study report

  • Post-Market surveillance report

  • Summary of safety and clinical performance (GSPR Final)

Design Changes template

  • Change requests

Design History File (DHF) template

  • DHF Index

Design Transfer templates

  • Release notes

  • System operating procedures

Clinical Investigation templates

  • Clinical trial monitoring plan

  • Clinical trial investigator brochure

  • Patient informed consent

  • Clinical evaluation plan

  • Clinical evaluation report

  • Clinical investigation plan

  • Clinical investigation report

SOPs templates

  • QMS Management

  • Document Management

  • Quality Records Control

  • Management Review

  • Internal Audits

  • Training

  • Complaint and Feedback

  • Corrective Action and Preventive Action

  • Supplier Management

  • Analysis of Data and Statistical Techniques

  • Unannounced or Announced Audits

  • Non-Product Computer Software Validation

  • Business Continuity & Disaster Recovery

  • Work Environment

  • Customer Management

  • Purchasing

  • Software Development Lifecycle

  • Risk Management

  • Usability Engineering

  • Software Configuration Management

  • Change Control

  • Design History / Technical File

  • Product Vulnerability Management

  • Unique Device Identification (EU)

  • Unique Device Identification (FDA)

  • Post Market Surveillance

  • Medical Device and Vigilance Reporting

  • Regulatory Impact Assessment

  • Regulatory Body Notification

  • Advisory Notices

  • Recalls, Corrections and Removals

  • Clinical Evaluation

  • Clinical Investigation / Data Management

Work Instruction templates

General QA templates
  • Management Review

  • QMS Change Request

  • Good Documentation Practices

  • Training Module

  • Complaint and Feedback Processing

  • CAPA Processing

  • Audits

Supplier templates
  • Supplier Qualification Approval and Monitoring

  • Purchase Order and Purchase Records

Post Market template
  • Production and Post-Market Monitoring

Regulatory template
  • Updating Regulations, Standards and Guidance Reference

Software Design and Development templates
  • Project Plan Documents

  • Device Hazard Analysis and Risk Analysis

  • Usability Risk Assessment

  • Cybersecurity Risk Analysis

  • Design Review

  • System Change Request

  • Software Configuration Management

  • Coding Standards

  • Software Code Review

  • Software Verification

  • Software Issue Reporting and Tracking

  • Software Code Release

  • Third-party software Used in Product

  • Development

  • Product Decommissioning

Available for the following packages:

  • Essential

  • Team

  • Company Included

  • Enterprise Optional

Learn more

Have questions about this module or want to see a demonstration? Book a free meeting with a solution expert!