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  • byteKultur GmbH Terry Harker

    Terry Harker

    Co-founder & Developer

    Wir haben davon profitiert, dass wir sehr schnell und einfach Risikoanalysen für unterschiedliche Produktgruppen erstellen konnten. Ein entscheidender Vorteil war, das die Inhalte unabhängig von der Form erstellt werden können.

  • byteKultur GmbH Terry Harker

    Terry Harker

    Co-founder & Developer

    Nullam a facilisis arcu. Vestibulum varius sed dolor nec consectetur. Phasellus faucibus aliquet ligula, vitae lobortis ex iaculis in. Aenean pharetra nibh consequat varius dictum. Praesent fringilla ut felis ac luctus. Nam a scelerisque est. Nunc efficitur accumsan nibh, a iaculis risus.

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Partners

Partners with us

We know what we do best and what others do better than us. Our Partners make sure that Aligned Elements customers get maximum returns with minimal effort from our system by providing services, trainings, content and on-boarding assistance. 

Quality and Regulatory Experts

We team up with an array of Quality and Regulatory experts that can solve your Medical Device Development and Manufacturing issues on your terms.

Quaregia - is a Swiss consultancy that supports life-science and medtech companies with regulatory affairs, quality management, and compliance across the entire product lifecycle, helping organizations navigate complex standards, streamline documentation, and bring safe, compliant products to market efficiently. Quaregia is the supplier of the Aligned eQMS SOP's and templates. Visit Quaregia

Keymkr - Keymkr are experts in Compliance Engineering and Product Testing for Medical Devices (MD and IVD). Furthermore, Keymkr develops and market MEDULUS, a software extension for Aligned Elements. MEDULUS makes it possible to create and maintain standards-compliant development documentation throughout the entire life cycle of a medical device using Aligned Elements. Visit Keymkr

Qadvis - QAdvis is a team of expert advisors in compliance, quality and productivity for the MedTech industry. We work with MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Visit Qadvis

ISS - ISS AG provides services for the development of medical devices, their introduction into the market and their maintenance. Typical services include embedded software development, regulatory affairs and clinical evaluation report writing, clinical research, quality management, qualification and validation. Visit ISS

Medidee - Medidee is your partner for medical devices and IVD compliance in Europe and USA. Medidee provides the necessary competencies internally to handle all aspects of your project, from the Design to the Certification. Visit Medidee

Inmedis - Inmedis connects IT and processes. Their services and know how include Regulatory Affairs, Quality Management, QM IT systems, Technical Documentation, Biocompatibility and Computer System Validation. Visit Inmedis

Commala LtdCommala offers a service that spans Medical Device Engineering, Regulation and Quality. From the big picture to the devil in the detail; Commala’s hands-on and pragmatic approach to development and engineering is aimed at helping your team get the most out of their assets. Visit Commala

IPP - IPP offers specialized services for medical devices manufacturers in all relevant areas to comply with MDR 2017/745. IPP provides the tool “Easy13485 QMS Software as Service,” to access your process landscape with binding and efficient instructions and the control of ISO 13485 compliance together with a standard-compliant and already filled quality management system. This saves both time and money to get started with your QMS right away. Visit IPP

Usability Experts

For assistance by and access to Human Factors / Usability / IEC 62366 Experts with Aligned Elements experience, reach out to our partners.

Use-Ingstands for usability engineers and at the same time expresses that our focus is always on representative users and their interaction with various technical products in the respective context of use. Use-Ing successfully supports companies in the medical technology, aeronautical engineering, software engineering, mechanical engineering, mobile machinery and geronto-technology sectors in the human-centered technology development of interactive systems. Visit Use-Ing

Umbrella UX - With our human factors and usability engineering competencies, we support companies in safety-relevant industries to minimize usage-related risks in their products, workflows or processes in order to avoid undesired events such as accidents or product recalls. Visit Umbrella UX

Educational Institution, Clusters and Cooperations

Aligned Elements is used at educational institutions where medical device development is taught.

Hochschule Furtwangen - Aligned Elements is used in the education of medical device at HS Furtwangen, teaching the concepts of Design Control Management. Visit HS Furtwangen

Swiss Medtech - Swiss Medtech is the association of Swiss medical technology, representing around 700 companies. We work closely with our members, informing them of essential developments and supporting them in the event of challenges. Aligned is a member of Swiss Medtech. Visit Swiss Medtech

Health Tech Cluster Switzerland - Health Tech Cluster is a network of manufacturers, suppliers, research and training institutions, service providers and investors in the health technology sector. Aligned is a member of the Health Tech Cluster. Visit the Health Tech Cluster

MDKU - Medical Device Knowledge Units (MDKU) is a non-profit organisation that develops an open source data model for the technical documentation of medical devices to speed up digitalization. Visit MDKU

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Join our partner network to our customers bring world-leading Medical Devices to the market using Aligned Elements 

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The ISO 14971 risk management tool

The ISO 14971 Risk Management Tool

Stay ISO 14971 compliant and in control

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Would you like to ...

  • End-to-end Traceability

    Quickly reach compliance with ISO 14971 - Application of risk management to medical devices?

  • ISO

    Do risk analysis your way and not the way a tool prescribes it?

  • Continuous Traceability

    Automatically ensure that your mitigations are implemented?

  • Traceability Tables

    Use pre-configured Potential Hazards from ISO 14971?

  • Traceability Tables

    Monitor the effect of your mitigations in a pre- and post-mitigation Risk Summary?

  • UNMITIGATED

    Be warned if you have incomplete risk coverage or unmitigated risks?

  • LESS

    Spend less time on maintaining documents?

Reduce the time spent on Risk Management!

  • End-to-end Traceability

    By easily tracing ISO 14971 risk controls / mitigations to your design inputs

  • ISO

    By automating checks for not implemented mitigations

  • Continuous Traceability

    By checking the completeness of your risk management in seconds

  • Traceability Tables

    By re-using mitigations to save time and ensure consistency

  • Traceability Tables

    By using configurable (preliminary) hazard analysis (PHA) and FMEA in a single tool

  • PRESS

    By creating and updating your risk management files at the press of a button

Start using Aligned Elements!

  • Lower costs

    Lower costs for development

  • Minimize work

    Minimize the work on development documentation 

  • Free up personel

    Free up personel for innovation

  • Faster to the market

    Bring your Medical Devices to the market faster 

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The Art Of Medical Device Documentation

The Art Of Medical Device Documentation

  • document less
  • reach compliance fast

  • meet your goals

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Get your Personal Online Demo!

And all of this in a single tool?

  • End-to-end Traceability

    Manage and Trace your Requirements

  • ISO

    Integrate your ISO 14971 compliant Risk Management 

  • Continuous Traceability

    Effectively manage and document your traceability matrix

  • Traceability Tables

    Define and execute Test Protocols

  • Traceability Tables

    Perform Design Reviews

No time to evaluate?

If you cannot spare the time to do your own evaluation, let us show Aligned Elements to you in a personal online demo!

This takes about 60 minutes and afterwards you know what Aligned Elements can do for you.

The online demo can also be an efficient kick-start for your own evaluation.

So go ahead and schedule a demo with us!

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Complete End-to-end Traceability for your Medical Device

Complete End-to-end Traceability for your Medical Device

  • ISO compatible

  • continuous

  • automated

More

Request an online presentation now

What you get from Aligned Elements

  • End-to-end Traceability

    End-to-end Traceability over all Design Controls

  • ISO

    Integrate Traceability with ISO 14971 Risk Assessments

  • Continuous Traceability

    Continuous Traceability Quality Monitoring with graphical coverage

  • Traceability Tables

    Predefined Medical Device Traceability Tables for IEC 62304

  • Traceability Tables

    Automatically generated and synchronized traceability documentation

How Aligned Elements helps your company

  • Lower costs

    Lower costs for development

  • Minimize work

    Minimize the work on development documentation 

  • Free up personel

    Free up personel for innovation

  • Faster to the market

    Bring your Medical Devices to the market faster 

Continue reading