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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.
Co-founder & Developer
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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.
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 Ltd - Commala 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
For assistance by and access to Human Factors / Usability / IEC 62366 Experts with Aligned Elements experience, reach out to our partners.
Use-Ing - stands 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
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
Join our partner network to our customers bring world-leading Medical Devices to the market using Aligned Elements
Stay ISO 14971 compliant and in control
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Quickly reach compliance with ISO 14971 - Application of risk management to medical devices?
Do risk analysis your way and not the way a tool prescribes it?
Automatically ensure that your mitigations are implemented?
Use pre-configured Potential Hazards from ISO 14971?
Monitor the effect of your mitigations in a pre- and post-mitigation Risk Summary?
Be warned if you have incomplete risk coverage or unmitigated risks?
Spend less time on maintaining documents?
By easily tracing ISO 14971 risk controls / mitigations to your design inputs
By automating checks for not implemented mitigations
By checking the completeness of your risk management in seconds
By re-using mitigations to save time and ensure consistency
By using configurable (preliminary) hazard analysis (PHA) and FMEA in a single tool
By creating and updating your risk management files at the press of a button
Lower costs for development
Minimize the work on development documentation
Free up personel for innovation
Bring your Medical Devices to the market faster
reach compliance fast
Manage and Trace your Requirements
Integrate your ISO 14971 compliant Risk Management
Effectively manage and document your traceability matrix
Define and execute Test Protocols
Perform Design Reviews
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!
ISO compatible
continuous
End-to-end Traceability over all Design Controls
Integrate Traceability with ISO 14971 Risk Assessments
Continuous Traceability Quality Monitoring with graphical coverage
Predefined Medical Device Traceability Tables for IEC 62304
Automatically generated and synchronized traceability documentation
Lower costs for development
Minimize the work on development documentation
Free up personel for innovation
Bring your Medical Devices to the market faster