Aligned

What Aligned does

Aligned AG is a Swiss-headquartered (Zürich) SaaS provider that sells application lifecycle management and electronic quality management software exclusively to medical device manufacturers. Its portfolio comprises two products: Aligned Elements, an intelligent Design Control Management system that drives creation of consistent, compliant Technical Files and Design History Files through requirement, risk, test, traceability, and document management; and Aligned eQMS, launched in November 2025, which extends coverage to document control, training, change management, CAPA, supplier, audit, equipment, and computer software validation workflows. The platform is purpose-built for medical device regulatory frameworks including ISO 13485, ISO 14971, IEC 62304, FDA QSR 820, EU MDR, EU IVDR, IEC 60601-1, IEC 62366, and FDA 21 CFR Part 11, with pre-configured templates and continuous regulatory content updates.

The technology stack is delivered as cloud SaaS with dedicated isolated servers per customer and selectable geographic data residency, supplemented by an on-premise installation option. AI capabilities introduced in 2025 — automatic test case drafting, trace recommendations, and title summarization — operate exclusively in the Aligned Elements Web Client and are applied to text-based design control content. The company holds ISO/IEC 27001:2022 certification and is GDPR/DSVO compliant, and integrates with Microsoft Entra for SSO. Distribution is direct enterprise sales combined with a 30-day free trial, supported by an implementation partner network and an academic partnership with the University of Furtwangen.

Aligned serves hundreds of medical device manufacturers across all device classes, with named enterprise customers including Coloplast, Epredia, Vetter, Inspire, Enovis, Tecan, and Sony Medical. Pricing is quote-based on team size and concurrent users, billed annually. The company is privately held, has 1–10 employees, has not disclosed any external funding rounds, and operates without a parent company, suggesting a bootstrapped, founder-led operating model since its 2006 founding. Leadership is anchored by CEO Anders Emmerich and Managing Director Karl Johan Larsson.

Name

Aligned

Legal name

Aligned AG

Website

https://www.aligned.ch

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

1–10 employees

Short description

Swiss-based SaaS provider Aligned AG sells Aligned Elements (Design Control Management/ALM) and Aligned eQMS to medical device manufacturers worldwide. The software is purpose-built for ISO 13485, FDA QSR 820, EU MDR compliance, with AI-assisted test case and traceability features.

Ownership category

akta.pro rank

Product category

Medical Device Compliance Software

NAICS

Computer Systems Design and Related Services (54151), Computer Systems Design Services (541512)

SIC

Services-Computer Integrated Systems Design (7373)

akta.pro primary industry

Industry/Vertical Cloud Platforms (e.g., Gov/Healthcare/Financial Cloud Regions) (HDABAAAL)

Keywords

• Medical device software
• Design control management
• Quality management system
• Regulatory compliance software
• Application lifecycle management

Headquarters

HQ city

Zürich

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Software Subscription (SaaS): Cloud-based subscription model for both Aligned Elements and Aligned eQMS products. Customers can deploy on SaaS or on-premise. Pricing is quote-based and tailored to team size, concurrent users, and responsibilities.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels6 records

Core offering

Aligned offers a cloud-based SaaS platform purpose-built for medical device companies, consisting of two products: Aligned Elements (intelligent Design Control Management / ALM for requirements, risk, test, traceability and document management leading to Technical File and DHF creation) and Aligned eQMS (electronic Quality Management System covering document control, training, change, quality events/CAPAs, supplier, audit, equipment and computer software validation management). Both are delivered as SaaS or on-premise, with AI-powered design-control assistance available in recent versions and pre-built templates for ISO 13485, ISO 14971, IEC 62304, FDA QSR 820, EU MDR, EU IVDR and other medical device regulations.

Product overview

Aligned offers a two-product portfolio for the medical device industry: Aligned Elements is an intelligent Design Control Management system for creating correct, consistent, and compliant Technical Files and Design History Files (DHF); Aligned eQMS is a comprehensive electronic Quality Management System that unites quality, regulatory, and development teams. Together, the products provide end-to-end coverage from design control through quality management, supporting compliance with ISO 13485, ISO 14971, IEC 62304, FDA QSR 820, EU MDR, and EU IVDR standards.

Differentiator

Problem solved

Functional benefit

Products and services

• Aligned Elements Intelligent Design Control Management software for medical device companies that drives correct, consistent, and compliant Technical File and DHF creation. It supports requirements management, ISO 14971 risk management, test management, traceability management, document management, consistency and completeness checking, and regulatory compliance, and is available with AI-powered features such as automatic test case generation, AI-suggested traces, and AI-generated summarized titles for design controls.
• Aligned eQMS Electronic Quality Management System (eQMS) that unifies medical device quality, regulatory, and development teams and ensures compliant quality while maximizing efficiency with minimal administration. Includes modules for document control management, training management, change management, quality event management (feedback, complaints, nonconformities, CAPAs, vigilance), supplier management, audit management, equipment management, and computer software validation management.

Quantifiable outcome

• 95% of customers experience increased confidence in their Technical Documentation
• +3 more outcomes

Named customers11 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability4 records

Feature6 records

Partnerships

Two partnerships are on record, tiered minor.

• USE-Ing. GmbHminorStrategic or Co-development PartnerUSE-Ing. GmbH, one of Europe's leading Human Factors and Usability Engineering agencies for medical device development, collaborated on usability engineering content and referenced in Aligned's expert articles on IEC 62366-1 compliance.
• University of FurtwangenminorOthersUniversity of Furtwangen uses Aligned Elements in their Medical Devices Human Factors Education program, teaching next-generation medical device experts using the software.

Scale indicators5 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Greenlight Guru: Greenlight Guru is a pure-play eQMS and design control platform purpose-built for medical device companies, offering quality management, design controls, risk management, and regulatory submission support. It directly competes with both Aligned Elements and Aligned eQMS in the same vertical SaaS niche.
• MasterControl: MasterControl provides an integrated QMS, document control, training, and design control platform heavily used by medical device and life sciences manufacturers. It overlaps directly with Aligned's eQMS and Elements offerings and is one of the most established competitors in regulated medical device quality software.
• Qualio: Qualio is a cloud eQMS focused on life sciences and medical device companies, providing document control, training, change management, and quality event management. It is a direct competitor to Aligned eQMS with comparable SaaS positioning and target buyer profile.
• ETQ (Hexagon): ETQ Reliance is an enterprise QMS platform serving manufacturers including medical device and life sciences companies, with modules for document control, CAPA, change, audit, and training management. It competes with Aligned eQMS at the higher end of the market.
• Jama Software: Jama Connect is a requirements management and traceability platform used for complex product development including medical devices, with strong emphasis on design controls, risk traceability, and live trace links. It directly competes with Aligned Elements on the ALM/design control side.
• Arena Solutions (PTC): Arena offers a cloud PLM/QMS platform with strong adoption among medical device and life sciences manufacturers for BOM, change management, design controls, and quality workflows. It is a direct competitor on the design control and product lifecycle side of Aligned Elements.
• ComplianceQuest: ComplianceQuest is a native Salesforce QMS platform with modules for document control, training, CAPA, audit, supplier, and design control, widely used by medical device and life sciences manufacturers. It is a direct competitor to Aligned eQMS with comparable target customers.

Broad incumbents

• Veeva Systems: Veeva's Vault Quality Suite provides QMS, content management, and regulated document workflows for life sciences and medical device companies. It is a broad incumbent with much larger scale and a wider portfolio (CRM, clinical, regulatory), but its Quality and Medical Device suites overlap with Aligned's value proposition.
• Polarion (Siemens): Siemens Polarion is an ALM and requirements management platform used across safety-critical industries including medical devices, with templates aligned to IEC 62304 and ISO 14971. It overlaps with Aligned Elements on requirements, risk, and traceability management.
• Siemens Teamcenter: Teamcenter is a broad enterprise PLM suite that includes requirements, design control, BOM, and quality capabilities used by large medical device manufacturers. While not a pure medical-device QMS, it competes for the same ALM and design control budget Aligned targets.

Market position

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/aligned_ag

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Aligned