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QMS in a box

Quality Management System (QMS) templates for Software as a Medical Device (SaMD) organizations

QMS in a Box provides a structured set of ISO 13485–aligned Quality Management System (QMS) templates designed for digital health and software-based medical device organizations.

All documents are provided in editable Word and PDF format and are structured as fill-in-the-blank templates with embedded questions and guidance notes to help you implement and adapt a compliant QMS for your organization.

Quality management system QMS for digital health tools and software as a medical device products aligned with iso 13485

What’s Included

Quality Management System Framework

  • Quality Manual template
  • Quality Policy and Quality Objectives templates
  • QMS Scope and applicability definition
  • Document control framework

Design & Development Controls

  • Design and Development Planning procedure
  • Design Inputs and Design Outputs templates
  • Design Review procedure and records
  • Design Verification and Validation overview
  • Design Transfer procedure

QMS Document & Record Control

  • Document Control procedure
  • Record Control procedure
  • Document Change Control process
  • Master Document List template

QMS Change Management

  • Change Control procedure
  • Impact Assessment template
  • Change Review and Approval records

Risk Management (QMS-Level)

  • Risk Management Procedure
  • Risk Management Planning template
  • Risk Review and Maintenance process

(Aligned with ISO 14971 at the organizational level)

Supplier & Outsourcing Controls

  • Supplier Evaluation and Selection procedure
  • Supplier Approval and Monitoring records
  • Outsourced Process Control procedure

CAPA & Nonconformance

  • Nonconforming Product procedure
  • Corrective and Preventive Action (CAPA) procedure
  • CAPA Investigation and Effectiveness Review templates

Complaints & Feedback

  • Complaint Handling procedure
  • Complaint Investigation records
  • Feedback and post-market input process

Internal Audits & Management Review

  • Internal Audit procedure
  • Internal Audit Plan and Checklist
  • Management Review procedure and agenda

QMS Training & Competency

  • Training procedure
  • Training Records template
  • Competency assessment framework

QMS in a Box Format & Guidance

  • Editable Word and PDF documents
  • Fill-in-the-blank structure for all templates
  • Embedded guidance explaining:
    • ISO 13485 requirements
    • How to tailor procedures to your organization
    • How processes interact with regulatory submissions

Standards & Frameworks

ISO 13485, ISO 14971

Who This Is For

  • Digital health and SaMD organizations implementing ISO 13485
  • Teams preparing for audits or regulatory inspections
  • Companies needing a scalable, practical QMS framework

Scope Clarification

This package provides organizational-level QMS templates aligned with ISO 13485.
It does not replace detailed IEC 62304 software lifecycle documentation or regulatory submission templates.

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