The Aligned eQMS is delivered with a complete set of 32 Standard Operating Procedures and 107 templates specifically developed for ISO 13485 certification.

This set, covering all types of medical devices, is designed to make you fully compliant with MDR, IVDR, ISO 13485, FDA 21 CFR 820, ISO 14971 and IEC 62304.

Use the Aligned eQMS Word Add-In to make organization specific changes or complement this set by uploading your own MS Office documents.

A single source-of-truth for your quality team with zero document duplicates, always up-to-date.

Eliminate documentation confusion by relying on a centralized hub for your QMS Documents, protected by secure and permission-based access.

A clear separation between formally released documents and documents currently being drafted (or being changed, reviewed or in the middle of an approval cycle) minimizes the risk of mistaking a non-released document for a released one.

With Aligned's FDA 21 CFR Part 11 compliant signatures, routing and approval of documents is automated.

Effective sign-offs, using sequential or parallel approval signature workflows. Optimize approval speeds by assigning signatures to roles instead of individual persons, using a "first-come, first-serve" approach.

Stay in the loop with automatic email alerts and designated "Assign to me"-dashboards, updated as soon as a signing action has been routed to you.

Accountability guaranteed by mandatory revision control, where each document change is stored into a chronological an unambiguous audit trail.

Aligned eQMS gives you the necessary mechanisms to guarantee that only released templates are used in your Technical Files.

Respond faster to audit and inspection demands by swiftly and accurately locating the relevant released document, leveraging the built-in full text-search, powerful filtering and extensive query possibilities.

Make training management easier with role-based Quality Management System training.

From training activities and records to CV:s and certifications, everything is linked and associated to each employee's profile for a clear, auditable record.

Connect Documents to Responsibilities / Roles and Required Training Effectiveness Levels to drive automated training activity creation.

Ensure the right employees are assigned the right training activities at the right time.

The correct training activities are automatically created when a document is released, or a new employee is onboarded.

Based on a user’s job Responsibilities / Roles and the type of document in question, the Aligned eQMS ensures proper alignment between documents and employees.

Notifications and actions are disseminated to the relevant employees affected by new or updated documents.

Ensure on-time Training completion with regular reminders and nudges.

Instantly see who has completed their training, who is in progress, and who is overdue.

Say goodbye to spreadsheets, manual checklists, and chasing people down. Our system tracks everything automatically, so you can focus on outcomes.

Change is not only unavoidable; it is essential for adjustments, optimization, and increased safety.

Support your team constantly navigating evolving regulations, customer feedback, design improvements, and manufacturing adjustment, with a smart change management system.

Track the full context, impact, and rationale behind every change to stay compliant.

Whether a change was driven by an event or an expected process improvement, clearly show the what, when, why, and how of any change.

Changes can be complex. Aligned eQMS assists you in breaking down your Change Requests into clear, actionable implementation tasks.

Assign and approve to automatically distribute individual Change Implementation Tasks to the right people.

As soon as a Task is assigned, the responsible person is notified via automated email alerts and can immediately start processing the task. 

Deadlines are tracked. Statuses are visible to the Change Owner. The Change is completed. The loop is closed.

"If it is not written down, it did not happen."

A regulated environment, like the Med Tech Industry, gives no quarters. Every change must be deliberate, documented, and done right.

The Aligned eQMS is built for medical device manufacturers and purpose built for efficiently achieve compliance with ISO 13485 and FDA 21 CFR Part 820.

With linked impact assessments, electronic approvals, and full audit trails, you will always know who did what, when, and why.

Give your teams a system that transforms change from a bottleneck into a strategic advantage — with structured tasks, real-time accountability, and minimal effort to reach compliance.

Feedbacks and complaints shall be taken seriously. Behind every Feedback is an opportunity. Behind every complaint is a patient, a clinician, a user, a story. And possibly: a risk.

With the Aligned eQMS Feedback and Complaint form, you collect and triage inputs and communication from stakeholders in a compliant manner, aligned with ISO 13485 8.2.1 and 8.2.2

A formal decision process, supported by e-Approvals gives you the compliance proof necessary to show that you did the right thing.

When a product does not meet specifications, be it incoming goods, goods in production or delivered devices, the Aligned eQMS is the principal place to track it.

Record containment, marking and storage actions taken to isolate the non-conforming product. Track product specific information such as batch ids, quantities, and timelines.

Create and assign Tasks to your team for parallel and swift resolutions. Monitor the status and ensure full closure ,all with real-time visibility.

When necessary, escalate the matter to a Nonconformity Assessment for deeper investigation and root cause analysis.

A nonconformity can originate from a number of situations and be related to a range of different quality artefacts.

It can be the result of an escalated Complaint. It can arise as an outcome of an Audit. It can emerge from a failed Computer Software Validation.

In the Aligned eQMS, Nonconformity Assessments are stored in a single location with clear references to other parts in the eQMS.

Get the full picture through detailed situational information collection and clear decision points, signed with e-Approvals and proper justifications.

Make use of a guided and thorough Root Cause Analysis process and set up association with similar Nonconformity Assessments. If necessary, escalate the situation to one or more CAPAs.

CAPA is the heart of an ISO 13485 compliant quality system and the most scrutinized part during audits.

We help you go beyond reactive fixes to proactive improvement, with structured steps and bulletproof documentation.

Define action plans with accountability, complete with owner, due date and assessment. Support your implementation with objective evidence of implementation and of effectiveness.

Ensure CAPAs are only closed when actions are complete, verified, and approved by designated roles.

Pick the right product and service partners with a risk-based ISO 13485 §7.4 / FDA 21 CFR 820.50 compliant process.

Use structured, audit-ready data to document the supplier selection criteria, candidates, and evaluation evidence for your selection.

Streamline the approval process with an automated approval, notification and sign-offs.

Manage, categorize, and continuously assess all your suppliers centrally in a single location.

Get full visibility into your supply-base and track their performance.

Close the loop by connecting all supplier QM related processes, such as Supplies Audits, Nonconformity Assessments, Equipment and more.

Products change. Suppliers change. Make sure suppliers still meet your standards with structured, risk-based re-evaluations.

Past performance does not guarantee future compliance. Never miss a supplier re-evaluation using auto reminders to the right person at the right time.

Demonstrate due diligence. Generate re-evaluation reports in seconds for audits or internal reviews.

For the smoothest possible audit experience, experts agree: prepare, prepare, prepare.

With Aligned eQMS you are in an excellent position to provide compliance proof of your continuously consistent QMS state with minimal effort.

Set up an Audit Program and plan all audit types well ahead in one central location. Consolidate internal, external, and supplier audits under one unified view.

Built-in compliance proof — with created audit programs that stand up to regulatory scrutiny with a documented, repeatable process.

With seamless access to previous findings and real-time QMS data, the planning and execution of targeted audits can be conducted with minimal effort and maximum impact.

Gather QMS artifacts automatically by pulling relevant documents, records, and previous audit results directly from your eQMS.

Drive insight-based audits by using past performance and recurring issues to guide where and how you audit.

Respond swiftly and systematically to audit findings by recording nonconformities, initiating corrective actions, and monitoring progress in real time.

With a clear action plan, you assign tasks, owners, and deadlines to make sure no audit finding is left unresolved.

Provide solid proof of continuous improvements through compliant records of audit result control, while monitoring sign-offs of completed follow-ups.

For Medical Device Manufacturers, Equipment used in manufacturing and development have significant impact on the quality of final device, and consequently also on the patient safety.

With your Equipment under close supervision, you add another layer of device quality, production reliability and, ultimately, safety to users of the device.

By planning ahead, you can prevent equipment failures and reduce potential disruptions.

Track tools and equipment with full visibility with status at a glance. Know the state of every piece of equipment with a complete maintenance and calibration history, including its connections to past quality events.

Use equipment only when approved and prevent misuse by blocking expired or uncalibrated tools.

Plan, assign, execute, follow up and sign-off on equipment calibration and maintenance activities.

Keep a complete and consistent audit trail of Equipment Control activities.

No-one likes scattered spreadsheets and outdated IQ/OQ/PQ documents.

Be faster with a system that uses item-based CSV management as the foundation for your CSV work.

Keep track of the software assets relevant to the success of your medical device in a single location.

You gain clarity, control, and confidence in knowing that your CSV landscape is always up-to-date.

Keeping the of records of your CSV assessments proves your systematic and compliant approach.

A risk-based CSV evaluation, leaning on ISO 13485 and FDA QSR 820 guides your decision process. By assessing impact, complexity, and intended use, the system helps you determine which software must be validated.

Your validation plans and reports are built on a transparent, traceable rationale that stands up to inspection.

And furthermore, being able to demonstrate the documented and deliberate reasons why you have not validated a particular software, is sometimes just as valuable for compliance as the CSV itself.

Our item-based system connects features, functions, requirements, with tests, either AI-supported scripted tests or exploratory tests, all depending on the verdict of your risk-based assessment.

Every change is tracked, every test traceable, providing a total transparency from concept to compliance. Continuous, real-time consistency checks make sure that no requirements remain untested, and no test slips through unexecuted.

Deliver traceable validation results designed for audit readiness and regulatory reliability.

Compliance doesn’t stop after go-live, and neither does the Aligned eQMS CSV process.

With built-in reminders, periodic assessments are not forgotten, and your CSV work remains complete, correct and compliant. You’ll know exactly when your systems need to be re-assessed due to changes in the software itself, its intended use, external regulation or your risk appetite.

This proactive process helps you stay ahead of regulators and avoid costly surprises, so validated stays validated, year after year.