Design Control

Design Control by SimplerQMS is a module within an all-in-one electronic Quality Management System (eQMS) built for medical device manufacturers. It allows organisations to create, organise, and maintain all technical documentation related to medical device design and development — including Technical Files (TF), Design History Files (DHF), Device History Records (DHR), and Device Master Records (DMR) — in a single, centralised cloud-based repository.

The module is intended for quality and regulatory affairs professionals who need to manage design documentation, support regulatory submissions such as EU MDR evaluations and 510(k) premarket submissions, and maintain compliance with standards including ISO 13485:2016, 21 CFR Part 820, 21 CFR Part 11, and ISO 14971:2019. It sits alongside other core QMS modules including change management, CAPA management, audit management, supplier management, and training management.

Document Creation and Management

• Supports creation of new documents using Word and Excel templates, as well as import of external documents into the system.
• Provides Template and Form Management features to enforce a standardised approach to document creation.
• Allows documents to be linked to multiple design control archives (TF, DHF, DHR, DMR) without creating duplicates.
• Uses metadata cards and dashboards to provide an overview of design control documentation across products, projects, and regulatory requirements.
• Supports migration of existing files into the centralised cloud-based repository.

Audit Preparation and Submission Handling

• Provides dashboards and an internal search tool to quickly retrieve documents during audits.
• Includes a document collection tool to compile technical documentation, DHFs, DMRs, and DHRs for regulatory submissions.
• Supports organisation of document collections for EU MDR evaluations and 510(k) submissions, with the same document linkable to multiple collections without duplication.
• Allows documents and collections to be exported to local storage for sharing with external partners, auditors, or regulatory bodies.
• Enables access restriction to specific project archives by assigning team members using metadata cards.

Change Tracking and Version Control

• Records all changes made to design documentation and provides time-stamped audit trails, revision history, and full traceability.
• Document versioning features keep documents current at all times.
• Tracks changes after design freezes through integration with the Change Management module.
• Supports creation of change request forms using templates, task assignment, electronic signatures, and enforcement of learning activities following changes.

Risk Management Integration

• Connects the Design Control module with the Risk Management module to support risk assessment during the design and development phase.
• Built-in templates support documentation of risk management processes.
• Risk documents can be related to design control files to support change in processes or products.
• Supports compliance with ISO 14971:2019 and ISO 13485:2016 during design and development.

Collaboration and Partner Communication

• Allows collaborators such as material suppliers, software providers, consultants, and external auditors to be associated with specific sites and departments using metadata.
• Supports location-specific document access to communicate new and updated files to relevant parties.
• Documents can be exported to local storage for sharing with collaborating partners when needed.

Training Management for Design Teams

• Includes training management capabilities to create learning rules and personalised assignments for team members.
• Supports multiple training material formats including videos, Word documents, PDFs, Excel tables, PowerPoint slides, and quizzes.
• Supports development of Design Control SOPs using built-in templates to enforce learning activities.
• Maintains records of education to support compliance with applicable regulations and standards.

Regulatory Compliance Support

• Supports compliance with EU MDR, EU IVDR, 21 CFR Part 11, 21 CFR Part 820, ISO 13485:2016, GxP, and EU GMP Annex 11.
• Software is validated according to GAMP5, with monthly re-validation performed by SimplerQMS.
• Complies with ISO 27001:2022 for data security.
• Provides electronic signature functionality in line with 21 CFR Part 11 and EU Annex 11 requirements.

Software Integrations and Deployment

• Integrates with project management and bug tracking tools, including Jira Software, via add-ons and API.
• Data is stored using Amazon Web Services (AWS) Cloud Data Centers, accessible from computers or mobile devices.
• Includes Microsoft Office integration.
• Implementation typically takes five to six weeks, depending on data migration volume and available organisational resources.
• Pricing is based on the number of user licences and includes implementation, user training, and ongoing support.

SimplerQMS Design Control is part of a broader eQMS platform that also covers document control, training management, change management, deviation management, CAPA management, complaint management, audit management, risk management, equipment management, and supplier management. The platform is developed by a team with over 30 years of life sciences experience and is used by more than 5,000 quality professionals.