Building Quality as a Team Effort – How Klavant prepares for ISO 13485 with MedQdoc
Your first 30 days with MedQdoc – a practical onboarding roadmap
Getting started with MedQdoc – a practical onboarding series for medical device and IVD companies.
This article is Part 4 of 4 in the onboarding series. Your first 30 days with MedQdoc focus on building an audit-ready eQMS step by step, without disrupting ongoing work.
The first month
The first month with a new eQMS sets the foundation for long-term success. A clear onboarding plan helps your team build structure, confidence, and audit readiness from day one – without slowing down daily work.
This roadmap shows a practical and proven way to get started with MedQdoc during your first 30 days.
A practical onboarding roadmap
The pace of your onboarding depends on internal resources, availability, and implementation scope. For some organizations, a more gradual rollout is preferred.
However, MedQdoc can also be implemented in as little as three weeks, including system onboarding and user training, when the right resources are available.
Week 1 – Set the foundation
During the first week, the focus is on structure and access. This is where you establish the basic framework for your QMS.
- Define user roles and permissions based on responsibilities
- Set up a folder structure aligned with your Quality Manual
- Import key procedures and templates
- Assign document owners to ensure accountability
- Set up a small working team responsible for the initial implementation
- Schedule an introduction session with the MedQdoc support team
Best practice:
Upload your QMS as it exists today and approve it as the first official version.
Then start updating procedures step by step.
This approach gives you a clear baseline and full traceability
to how your QMS looked before implementing MedQdoc.
Week 2 – Start working in MedQdoc
In week two, upload your core QMS documents and perform transfer approval. From this point, all QMS changes and document control are managed directly in MedQdoc, including version control, audit trails, and traceability.
Documents are reviewed, updated, approved, and published using the MedQdoc document lifecycle.
- Create new document versions representing draft and work-in-progress states
- Send documents for review and approval using the MedQdoc lifecycle and defined workflows
- Publish approved documents automatically or on defined effective dates
- Use electronic signatures for reviews and approvals
- Link documents to processes to improve traceability and compliance
Note: Ensure that training is performed for users based on their assigned roles and responsibilities in the system. Training records should be linked to the approved documents.
Week 3 – Build traceability and control
With core documentation in place, week three focuses on reviewing which QMS documents need to be updated and defining a transfer plan. This strengthens traceability to the previous QMS and ensures continued regulatory compliance.
- Decide which QMS procedures and records will be replaced or managed using the Case Module
- Connect documents to CAPAs and change records
- Ensure training is performed for the core working team and plan training for other users, with training records linked to approved documents
- Verify audit trails for reviews and approvals
Week 4 – Be audit-ready
By week four, your QMS should be stable and ready to demonstrate control and compliance.
- Review document status across the system
- Perform an internal audit check using MedQdoc evidence
- Confirm roles, permissions, and workflows
- Ensure users are trained according to their system roles
Example: Creating a document transfer plan
When transitioning from a legacy system or shared drives to MedQdoc, it is recommended to define a document transfer plan. This ensures that documents, records, and technical documentation are migrated in a controlled and traceable way.
A transfer plan does not need to be complex. The goal is to agree on scope, responsibilities, and key milestones before starting the migration, and to ensure that no important activities are missed in order to maintain regulatory compliance.
What a transfer plan typically includes
- Project objectives – for example, maintaining traceability and ensuring correct transfer of controlled documents
- Defined scope – QMS documents, records, technical documentation, and case management data
- Roles and responsibilities – what is handled by MedQtech and what is the customer’s responsibility
- Key milestones – data freeze, transfer start, review, approval, and go-live
- Regulatory considerations – including change control and notification to notified bodies when required
In a typical MedQdoc implementation, the transfer plan also defines how legacy data is archived, how traceability is maintained, and how transferred documents are reviewed and approved in the new system.
MedQdoc provides an onboarding plan and checklist to ensure that no important milestones or compliance-related activities are missed.
For larger implementations, the transfer plan can span several weeks and include detailed milestones for document migration, records, technical documentation, and case management data.
From onboarding to daily confidence
After the first 30 days, MedQdoc becomes a natural part of how your organization works. Instead of preparing for audits, you stay audit-ready every day, with clear ownership, traceability, and control built into daily processes.
Get onboarded faster with the MedQdoc team
The MedQdoc team supports companies in setting up traceable workflows from the start. With experience from medical device and IVD audits, the team helps ensure your system is structured for long-term compliance.
Getting started with MedQdoc – full article series
Next step: start with confidence
If you want to move away from folders and spreadsheets and toward a structured, audit-ready QMS, MedQdoc helps you get there – step by step.
Internal references
External references
Frequently asked questions
Are electronic signatures in MedQdoc compliant with 21 CFR Part 11?
Electronic signatures in MedQdoc are designed to support regulatory expectations from 21 CFR Part 11, as well as ISO 13485, FDA QSR, MDSAP, EU MDR, and IVDR.
Can we control who is allowed to sign documents?
Yes. MedQdoc uses role-based permissions and workflows to control who can create, review, and approve documents. Only authorized users can apply electronic signatures.
Is two-factor authentication required for electronic signatures?
Two-factor authentication is optional and can be enabled to provide additional security, depending on your organization’s policies and regulatory requirements.
What happens if a document is changed after it has been signed?
What happens if a document is changed after it has been signed?
A signed document cannot be changed. If updates are required, a new document version must be created.
The existing approval remains valid while the new version is in draft status. Only after the new version has completed the review and approval workflow does it become published, and the previous version is automatically archived.
This ensures that every electronic signature is always linked to the correct and approved document version.
Can auditors see the full signature history during an audit?
Yes. MedQdoc provides a complete audit trail showing who signed, when the signature was applied, and which document version was approved.
MedQdoc is used across the medical device industry
