MedQdoc FAQ

MedQdoc includes a comprehensive set of ready-to-use templates developed by medical device quality and regulatory experts.

The templates are designed to support quality management system requirements aligned with ISO 13485 and FDA QSR, covering areas such as management responsibility, design and development, risk management, and document control.

Yes. MedQdoc includes structured templates to support the preparation of technical documentation for both EU MDR and IVDR.

These templates are intended to support regulatory compliance by providing a clear and consistent structure for required documentation. Final content and regulatory responsibility remain with the manufacturer.

Yes. MedQdoc allows organisations to configure and adapt process maps to reflect their internal workflows and quality processes.

Process maps can be modified using built-in configuration tools, supporting alignment with organisational structure and regulatory requirements.

Yes. MedQdoc provides controlled document management including version control, approval workflows, and access management.

This supports the use of approved and current documentation within regulated quality processes.

The validation support documentation is accessible through the MedQdoc portal and provides customers with supporting material intended to assist in their system validation activities.

Final responsibility for system validation, including assessment of intended use and configuration, remains with the customer. MedQdoc provides guidance and access to relevant documentation that may be referenced within the customer’s quality management system to support validation activities.

Customers are welcome to perform a supplier audit of the MedQdoc service.

Validation support documentation may include items such as validation strategy, validation planning, risk analysis, test protocols, and traceability documentation.

The scope and use of validation documentation should be determined by the customer based on intended use.

MedQdoc is designed to support quality system requirements aligned with FDA 21 CFR Part 820 by providing structured document control, traceability, and quality workflows.

Templates and system functionality are aligned with both FDA QSR and ISO 13485 requirements to support efficient and consistent quality management processes.

MedQdoc includes functionality designed to support compliance with FDA 21 CFR Part 11 requirements, such as controlled access, audit trails, and electronic signature workflows.

Use of these functions must be assessed and validated by the customer based on intended use and regulatory requirements.

MedQdoc includes case management functionality that can be configured to support processes such as CAPA, complaint handling, nonconforming products, change management, and supplier-related nonconformities.

These workflows are configurable to align with organisational processes and regulatory expectations.

Learn more about the MedQdoc Case Management module.

Case Management

Yes. While MedQdoc is structured to support ISO 13485, the system can be adapted to support other ISO management system standards such as ISO 9001, ISO 27001, and ISO 14001.

Adaptation depends on organisational requirements, scope, and configuration.

Yes. MedQdoc is designed to be configured using built-in tools without the need for custom software development.

This allows organisations to adapt workflows and structures while maintaining system integrity.

Yes. MedQdoc is designed to scale as organisational and regulatory requirements evolve.

Additional users, workflows, and modules can be added over time based on organisational needs.

MedQdoc offers structured onboarding, training, and implementation options based on the level of support required.

The approach depends on factors such as organisational timelines, existing quality systems, and prior experience with regulated quality management systems.

Once the licence agreement has been finalised, a dedicated MedQdoc cloud environment is prepared for the organisation. In most cases, the system is available within approximately 1–2 weeks to allow the organisation to get started.

Introductory training, typically up to two hours, is included to support initial system use and onboarding.

Additional training for users or system administrators may be provided as required.

MedQdoc provides quality and regulatory consulting services, as well as project management support, when required.

These services are provided under separate agreements and do not replace the customer’s regulatory responsibilities. MedQdoc may also provide access to senior quality and regulatory advisors to support regulatory preparedness and quality system activities throughout the project.

MedQdoc is designed to support organisations operating under regulated medical device requirements, including ISO 13485, EU MDR (2017/745), IVDR (2017/746), and FDA QSR (21 CFR Part 820), as well as quality system requirements applicable under the Medical Device Single Audit Program (MDSAP), including regulatory frameworks in Canada and Australia, without adding unnecessary complexity.

MedQdoc includes access to the software platform along with standard customer support (email) and access to documentation through the MedQdoc portal.

Services may include onboarding support, user guidance, and access to validation support documentation, depending on the selected service level.

Yes. MedQdoc offers onboarding and training services to support effective use of the system.

Training may be delivered through guided sessions, documentation, or other formats depending on organisational needs and scope.

MedQdoc provides customer support to assist with system usage, configuration questions, and general inquiries.

Support availability and response times depend on the agreed service level.

Yes. MedQdoc provide support related to system use and documentation during audits or inspections when requested.

Audit outcomes and regulatory interactions remain the responsibility of the customer.

Yes. Customers are welcome to perform supplier audits of the MedQdoc service as part of their supplier management and quality processes.

Yes. Ongoing support is available after implementation in accordance with the selected service agreement.

Support services may be adjusted as organisational needs evolve.

Yes. MedQdoc provides quality and regulatory consulting services delivered by experienced professionals to support organisations with regulatory strategy, quality system development, and regulatory preparedness.

All consulting services are provided under separate agreements. Final responsibility for regulatory compliance and regulatory decisions remains with the customer.

Support requests are typically handled through MedQdoc’s customer support channels, primarily via email, as outlined in the applicable service level agreement.

Requests are managed in accordance with agreed service levels. Additional service level agreements may be established to provide, for example, an appointed contact person or extended support options.

MedQdoc is a ready-to-use medical device eQMS with over 160 templates and technical documentation included. It is packed with features including record management, version control and audit trails, which not only make it easy to use but also save you time. MedQdoc also offers a simple search function and intelligently links documents and procedures with related process maps, documents and cases for easy navigation. There are no expensive add-on features – everything is included in your standard subscription.

Yes. MedQdoc is cloud based, so has the flexibility of being available to use anywhere in the world. While we are headquartered in the Nordics, we operate globally and have a number of international customers. Currently MedQdoc is available in English only.

MedQdoc data is hosted in Sweden at GleSYS Data Centers, an EU-based hosting provider.

GleSYS Data Centers operate certified data centers and hold certifications including ISO 9001:2015 and ISO/IEC 27001:2022.

MedQdoc data is hosted in a secure cloud environment with controlled access and regular backup routines managed by the hosting provider.

Security and data protection measures are aligned with recognised information security practices. Details regarding data protection and backup arrangements are described in the applicable service level agreement.

The customer retains full ownership of all data stored in MedQdoc.

MedQdoc does not claim ownership of customer data and processes data solely for the purpose of providing the service.

Yes. Customers can download their data using the available export and download functionality provided within MedQdoc.

This allows customers to retain access to their information outside the system.

For practical, step-by-step instructions on how to download published documents in bulk, please visit the MedQdoc Help Center.

If a customer chooses to leave the MedQdoc service, they retain the right to download their data prior to termination in accordance with the agreement.

Data handling and retention after termination are managed in line with contractual terms and applicable data protection regulations.

For detailed, step-by-step instructions on how to export data from MedQdoc, please visit the MedQdoc Help Center.

Yes. MedQdoc supports export of selected data and documents as a ZIP file, with the option to include a JSON file containing associated metadata.

This functionality allows organisations to retain access to their information outside the system and supports data portability, audits, and internal reviews.

For detailed, step-by-step instructions on how to export data from MedQdoc, please visit the MedQdoc Help Center.

Customers may request information relevant to supplier qualification and data protection as part of their supplier management processes.

Supplier audits may be conducted in accordance with agreed procedures and contractual terms.

Upon request, MedQdoc can provide documentation relevant to data protection, hosting, and information security in accordance with applicable agreements and available service documentation.

This may include information on hosting arrangements, certifications held by the hosting provider, and relevant elements of MedQdoc’s quality management system.

Yes. MedQdoc can be implemented in a phased approach, allowing organisations to start with selected functionality and expand over time.

Additional modules and users can be added as organisational and regulatory needs evolve.

Yes. MedQdoc offers subscription options that vary based on factors such as the number of users, selected modules, and service scope.

Subscription levels are defined to allow flexibility as organisational requirements change.

For information about subscription levels, please refer to our pricing page.

Introductory onboarding is typically included as part of the MedQdoc subscription to support initial system use.

The scope of included onboarding depends on the selected subscription and service agreement.

For information about subscription, please refer to our pricing page.

MedQdoc is licensed on a subscription basis.

Licensing is typically based on factors such as the number of users, selected modules, and agreed service scope.

For information about pricing, please refer to our pricing page.

Yes. Subscriptions can be adjusted as organisational needs change, for example by adding or removing users or modules.

Any changes to the subscription are handled in accordance with the applicable agreement.

No. Professional services such as extended onboarding, regulatory consulting, or project management are offered separately from the standard subscription.

The scope and terms of professional services are defined in separate agreements.