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