Dive into the rich feature set of Aligned Elements and smart solutions you can use to accelerate your Medical Device Development.
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| Browser | Currently stable release of Edge, Edge Chromium, Google Chrome, Firefox or Safari |
| MS Word | Standalone Word 2019 or later (32-bit or 64-bit) or Word 2013 or later with Office 365 |
| Processor | 2 cores |
| RAM | 8 GB |
| Hard Drive | 250 GB |
| Operating System | Windows Server 2012 or higher |
| Database Server | Aligned Elements uses Microsoft SQL Server for persistence. |
| SQL Editions | SQL Server Enterprise, SQL Server Standard, SQL Server Web and SQL Server Express with Advanced Services are supported. |
| SQL Versions | SQL Server versions 2005, 2008, 2012, 2014, 2016, 2017, 2019 and 2022 are supported. |
| Web Server | Aligned Elements uses Microsoft IIS Web Server. |
| Version | IIS 8 or higher |
| RAM | 4 GB |
| Hard Drive | 2 GB Free Space |
| Operating System | Windows 7, Windows 8, Windows 10, Windows 11 |
| MS Word | Word 2013 or later (32-bit or 64-bit) |
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Find out more about our package offerings below!
Design Control ALM
650 €
per month
Incl. 2 Floating Licenses
billed yearly
Popular
Starter Package
1000€
per month
Incl. 3 Floating Licenses
billed yearly
Full Package
2085€
per month
Incl. 5 Floating Licenses
billed yearly
Design Control ALM
400€
per month
Incl. 2 Floating Licenses
billed yearly
Popular
Starter Package
850€
per month
Incl. 3 Floating Licenses
billed yearly
Full Package
1830€
per month
Incl. 5 Floating Licenses
billed yearly
| Aligned Elements | eQMS Starter | eQMS Full |
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| Flexible Requirement Management |  |
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| ISO 14971 Risk Management | |
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| AI-Driven Verification Management | |
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| Design Validation Management | |
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| End-to-End Traceability | |
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| Automated Consistency Checks | |
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| Integrated Design Reviews | |
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| Use Scenario & Task Management | |
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| Powerfull Tech Doc Reporting | |
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| Integrated DHF Index | |
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| E-Signatures | 2000 EUR (one-time payment) | |
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| Included SOP:s | - |
SOP101 Human Resources SOP200 Design and Development SOP204 Software Development SOP208 Cybersecurity Management SOP209 Released Software Management SOP300 Documents and Records SOP301 Performance Evaluation SOP302 Change Management SOP303 Infrastructure SOP304 Supplier Handling SOP305 Risk Management SOP306 Usability Engineering SOP307 Labeling SOP308 Validation of Computer Software _____ 10 000 EUR (one-time payment) |
All SOP:s in Starter Pack SOP100 Management SOP102 Audits SOP103 PMS SOP104 Complaints and Vigilance SOP105 Corrective and Preventive Action SOP106 Nonconforming Product SOP201 Purchasing SOP202 Production SOP203 Sales SOP205 Incoming Inspection SOP206 Storage Packaging Delivery SOP207 Technical Service SOP301 Clinical Evaluation SOP309 Statistically Valid Sampling SOP310 Process Validation SOP311 Equipment Control SOP312 Device Cleanliness Sterilization Contamination Control _____ 20 000 EUR (one-time payment) |
| Centralized and Secure Repository | - | |
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| Version Control | - | |
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| Audit Trail | - | |
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| Automated Workflows | - | |
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| Automated Action Assignment | - | |
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| Training/Document Linking | - | |
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| Training Progress Tracking | - | |
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| Software Tool Library | - | |
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| Risk-Based Validation Assessment | - | |
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| GMP & FDA 21 CFR Part 11 Assessment | - | |
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| Validation Planning | - | |
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| Validation Reporting | - | |
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| Periodic Re-evaluation | - | |
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| Feedback & Complaints Management | - | - | |
| Nonconforming Products | - | - | |
| Nonconformity Assessments | - | - | |
| CAPA Management | - | - | |
| Vigilance Reporting Management | - | - | |
Getting up and running fast is important for most of our customers. To provide best possible fit between Aligned Elements and your existing organization, we offer the following add-ons:
| Configuration Support | 3500 € | Aligning with your Development ProcessWe configure Aligned Elements according to your quality management system for seamless integration with your existing Development processes and templates. |
| On-Site User Training | 2500 € | On-site User TrainingFull-day training of up to 12 of your employees on your company site. The training warrents a certificate of completion if the final test is passed. |
| Online User Training | 1200 € | Online User TrainingFour two-hour online sessions for 12 users. The training warrants a certificate of completion if the final test is passed. |
| Integration with External System | 2000 € | Integration with External SystemIntegrate Aligned Elements with Jira, TFS, Enterprise Architect, GitHub and many other system to get the most out of your existing infrastructure. |
| Integration with Automated SW Tests | 2000 € | Integration with Automated SW VerificationLeverage existing automated software tests in your traceability. Integrate Aligned Elements into your continuous build chain and automatically export results from your automated software tests into Aligned Elements. |
| Consulting Services | Deployment, Quick Start and Validation ServicesIf you need further help, we assist you with tasks such as:
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Ask us for a tailored pricing quote!
Find current and previous versions of Aligned Elements and related applications below.
Contact us and we'll assist you with your installation questions.
Let us know how we can help and we'll do our best to answer within the next 24 hours.
Klingenstrasse 37
8005 Zürich
Switzerland
09:00 - 18:00 CET
We are Aligned. Our purpose is to assist our customers to develop innovative Medical Device in less time, using less resources.
Aligned was founded in 2006 by a team of experienced medical device developers with extensive and international background in the Life Science Industry.
Our clients are manufacturers, end-customers and sub-suppliers in the medical device industry, companies who develop and market products which are subjects to regulatory compliance such as FDA Quality Systems Regulations or the EU MDD/MDR and IVDD/IVDR.
Our goal is to enhance our customer's capabilities in how to rapidly and successfully create quality compliant medical devices through excellence in regulatory documentation.
"There must be an easier way to document than this!"
We loved developing medical devices!
Not only was it exciting (it still is!), innovative and creative. It also felt meaningful; doing something that could benefit the health of potentially thousands of patients and users.
But then there was the documentation... It was always there – with us putting in endless hours on completing it, piling up as a vast mountain of binders. It sometimes felt like we were spending more time documenting than innovating. All we wanted to do was to develop devices and here we were, conducting frustrating, menial, repetitive documentation tasks.
We had fantastic, state-of-the-art engineering tools at our disposal, but for documentation we were stuck with Word and Excel. The resulting work was as you could expect. Auditors kept finding inconsistencies, errors and gaps and no matter how many times we reviewed our own documents, errors kept slipping through. Our confidence in our own documentation work was ailing at best.
We were convinced that there must be a better way to handle the documentation work than the way we were doing it. We were also convinced that medical device companies all over the world probably felt just the same way as we did.
In 2006, we started to work on Aligned Elements with the explicit goal to build a solution that could reduce the amount of work spent on development documentation while, at the same time, make sure that the resulting documentation was as error-free as possible.
Today, many years later, Aligned Elements has grown and expanded with the input from our customers, helping us to find smarter and better ways to reduce the documentation effort. We keep a close eye on regulatory changes and the challenges they entail and always, always ask ourselves, “how we can help our customers to become compliant with the least possible effort?”
At Aligned, we have our roots knee-deep in the everyday-life of medical device development and the documentation challenges that come with it.
Like you, we want medical device development to be about innovation. Afterall, that is where your hard-earned expertise lies, where you can bring most value and, quite frankly, what you were hired to do!
Aligned provides Aligned Elements, an ALM system to ensure compliant development documentation for regulated products in the Medical Device Industry.
We assist our clients in developing, manufacture and market regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.
At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration.
We strive to build value that last and therefore stay deeply involved with the undertakings of our clients until we are sure that sustainable results are achieved.
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