Get a quote designed to your needs!
Share your requirements with us, and we’ll prepare a personalized quote tailored to your unique medical device development situation.
The more details you provide, the better we can shape an offer that truly meets your needs.
Minimize the Technical Documentation efforts and speed up
the time-to-market with supercharged Design Control and eQMS Management.
We bring medical device companies the means to efficiently handle their quality, compliance and technical documentation tasks.
Design Control Management
Unlock the massive potentials of Design Control-centric Technical Documentation building. Accelerate development and deliver complete, correct and consistent technical files.
eQMS Quality Management
Automating and distributing quality tasks frees up time to focus on what matters. Continuously elevate your compliance level and stay ahead in a changing regulatory landscape.
For R&D Teams
AI-Driven Design Control Management that lets you focus on the real development! Generates consistent, complete and correct Technical Files with minimal effort.
For QA/RA Teams
Complete quality and regulatory tasks with ease to remain continuously compliant. Say goodbye to the nights and weekends spent prepping for audits and submissions.
Of our customers experience an increased confidence in their Technical Documentation
Of our customers eliminated all missing traces with Aligned Elements
Of our customers report high satisfaction with the Aligned solution.
Of our customers experience an increased productivity with Aligned products
Try aligned elements 30 days for free!
We started Aligned to give you more time. Time to bring life-changing medical devices to patients.
Reducing your burden of documentation and administration to get there faster, is our sole purpose.
If you want to focus on what you do best, we are the right choice.
All our customers create medical devices. This is the market we know and the only one we care about.
We monitor market trends closely, building new features in anticipation of regulatory change.
If you want to stay ahead of the curve, we are the right choice.
How did we get here?
By listening.
Our products keep reaching new heights through direct and continuous collaboration with our customers.
If you want a say in the making of the tools you use, we are the right choice.
2025-12-11
2025-11-30
2025-11-15
2025-10-27
Our integrated eQMS and Design Control systems ensures alignment with ISO 13485 with controlled and auditable processes.
Built to support all steps of medical device compliant risk assessments in our highly configurable design control system.
Medical Device Software development: supported and managed with our pre-defined IEC 62304 Design Control templates.
With Quality Mgmt and Design Control capabilities designed for FDA QSR 820, your journey to US market access begins here.
Kickstart your implementation for the european market with our GSPR requirement catalogue from the EU MDR Annex I.
Hit the ground running and start your compliance journey with a ready-to-go GSPR checklist from the EU IVDR Annex I.
Address essential electrical, mechanical, and environmental safety requirements with a system designed for IEC 60601-1.
Connect your Use Scenarios and interface design to risk assessments, formative and summative testing in Aligned.
Our systems provide FDA QSR Part 11 compliant handling of electronic records and signatures, including audit trails & action monitoring.
Customer Stories and Design Control Management Best Practices and Lessons drawn from hundreds of Medical Device Development Cases.
Sign up with us and be the first one to get new resources and blog posts on Best Practices, Lessons Learned and implications of Regulatory updates.
Get Started With a Free Trial Today!
No Credit Card needed!
If you need a trial extension, just let us know.
Don't miss out our follow-up support while you try aligned elements and receive tips on a regular basis!
If you want assistance to try your own QMS and/or development process in Aligned Elements, we'd be happy to assist you and work out a trial configuration for you.
Seeing your existing development documentation data in Aligned Elements can make it easier for you to assess how the system could assist your organization. We can help you parse and import your existing documentation into a test project.
Feel free to contact us if you have any questions.
[forms ID=1]
to join our growing list of customers using aligned elements to save time and focus on the interesting part of developing medical devices.
| Company | Instrument Category |
|---|---|
| Abbott | Ablation Catheter |
| Abingdon Health | Diagnostic Rapid Tests |
| AgenaBio | Genotyping |
| AnchorDx | Cancer genomics, genetics and bioinformatics |
| Anvajo | Blood Analysis Instruments |
| AOT | Cold Ablation Robot-guided Laser Osteotome |
| ASSKEA | Aspirators |
| Athena Medical | Medical Trolleys, Screens and Accessories |
| AVA Women | Fertility Tracker |
| Bionano | Optical genome mapping |
| Biotronik | Implants |
| Bambi Medical | Wireless monitoring devices |
| Benchmark Electronics | Wireless Monitoring Systems |
| Biocartis | Molecular Diagnostics |
| Baebies | Medical Equipment Manufacturing |
| Bioscentia | Laboratory Diagnostics |
| BoSonic | Digital Asset Trading |
| BioRad | Diagnostic Instruments |
| BIT Group | Contract Development |
| Brighter | Mobile Health |
| Cavidi | HIV Diagnostics |
| Celon Pharma | Integrated pharmaceutical company |
| Centerline Biomedical | Endovascular Surgery Platform |
| CN Bio Innovation | Organ-on-a-chip |
| CN Systems | Hemodynamics |
| CorTec Neuro | Implantable neurology products |
| Coloplast | Wound care |
| Code Refinery | Medical Device Engineering Consultants |
| CoMind | Non-invasive neural sensors |
| CTC Diagnostics | Sample Handling |
| Dawn Clinical, 4s Information Systems | Medical Device Software |
| DATA Corp. | Medical Device Software |
| Decision Sciences Medical | Advanced Image Analysis |
| Diality | Dialysis Machines |
| DJO Global | Orthopedics, sports and health products |
| DNA Electronics | Genomic Diagnostics |
| Dr Langer Medical | Neuromonitoring, Neurostimulation |
| Ellex | Ophtamology |
| Ergoline | UV- & Lichttechnologie |
| Exciscope | X-Ray Microimaging |
| Emblation | Microwave Therapy |
| Endosense | Catheter ablation for the treatment of cardiac arrhythmias |
| Escatec | Medical Device OEM Manufacturer |
| Everex | Medical Device OEM Manufacturer |
| Exini | Image Analysis |
| Ecomedics | Online Medical Equipment |
| Figur8 | Musculoskeletal health |
| Fluidic | Protein Analysis |
| Fluidnet | Infusion Systems |
| Fraunhofer-Institut für Biomedizinische Technik IBMT | Medical Device Prototyping |
| Geuder | Devices for Ophthalmic surgery |
| Goal3 | End-to-end clinical support system |
| Grossenbacher Systeme | Control Display, Medical Electronics & EEMS |
| GratXRay | Breast Cancer Imaging |
| Haughton Designs | Medical Device Consultants |
| Heinemann Medical Technology | ENT treatment and diagnostics |
| Hemotune | Magnetic Blood Purification |
| IF Test | Medical Device OEM Manufacturer |
| IH Medical | IVF Solutions |
| Integrated Scientific Services | Medical Device Engineering Consultants |
| Implantica | Implant for prevention of gastroesophageal reflux |
| Inspire Medical Systems | Neurostimulation Device |
| Sencure | Bio- sensing wearable device |
| JawSense | Tools for bruxism & TMD |
| Konplan | Mechatronic and MedTech |
| KEYMKR | Consultant Service Provider |
| Labitech | Diagnostic Analysers |
| Lifelens | Bio- sensing wearable device |
| Livetec Ingenieurbüro GmbH | OEM Developers |
| Lohmann & Rauscher | Wound Care, Opthalmology, OR Products |
| MBV | Air samplers |
| Medyria | Endovascular Catheters |
| Megin | Brain Imaging |
| MPS AG | Linear bearings and miniature ball screws |
| MinMaxMedical | Surgical robotics and computer-assisted medical interventions |
| MIDI PD | OEM Developers |
| Mycartis | Analysis of Clinical Biomarkers |
| MyoSwiss | Wearable Robotics |
| Mölnlycke Healthcare | Wound Care |
| Nanocellect | Cell sorters |
| Nanoomtech | Automated External Defibrillator |
| NE Scientific LLC | Medical Image Analysis, Modelling, Visualization |
| Nouvag | Medical and Dental Powertools |
| Nuvia Healthtec | Radiodiagnostics, radiotherapy, nuclear medicine and radiopharmacy |
| Oculox Technology | Micro and laser technology |
| Oertli Instruments | Ophtamology Therapy |
| Oculocare | Eye health |
| Organ Assist | Organ Perfusion Systems |
| Orthopediatrics | Pediatric orthopedic instruments |
| Orlight Laser | Surgical lasers |
| Osseointegrations | Custom Implants |
| OstPunkt | Medical Device Engineering Consultants |
| PA Consulting | Medical Device Engineering Consultants |
| Pass | Medical Device Consultants |
| Perimed | Peripheral Vascular Diagnosis |
| Peripal | Connection of dialysis tubings |
| Peter Lazic | Microsurgical Instruments |
| Pjur | Lubrications |
| Portal Instruments | Needle Free Injections |
| Presidio | IT Consultants |
| Promega | DNA STR Analysis |
| PTW Dosimetry | Radiation Therapy |
| QuantumDX | Molecular Diagnostic Systems |
| Qiagen | Molecular Diagnostics |
| RegenLife | Neurotech and Photomedicine |
| Remp | Sample Management |
| Rotarex S.A. | High pressure valves, tube fittings and pressure regulators |
| Real Heart AB | Heart and Lung machine |
| ReinVAD | Modern Cardiac Support |
| SALTS | Urostomy and Stoma care products |
| Scanco Medical | CT Scanners |
| Schaer Proton | Proton Therapy |
| Solve | Medical Device Engineering Consultants |
| Sony Mobile Communications | Health Tech |
| Stilla | PCR Systems |
| St Jude Medical | Implantable Heart Pump |
| Storz Medical | Shock wave therapy |
| Super Computing Systems | Medical Device Engineering Consultants |
| T2Biosystems | Blood test Instruments |
| Tecan | Immunodiagnostics, Molecular Diagnostics |
| Thermo Scientific | Tissue processing for anatomical pathology |
| Thermotek | Thermal Therapy Solutions |
| Thoratec (Abbott) | Heart Pumps |
| TMSi | Measurement Systems for electrophysiological parameters |
| Universitätsklinikum RWTH Aachen | Medical Modelling |
| Varian | Brachytherapy |
| Vectura | Inhalation Devices |
| Vetter Pharma | Aseptically pre-filled Application Systems |
| Vision Gate | Software for 3-Dimensional Cell Imaging |
| Volpi | Optoelectronic solutions |
| VOSS Healthcare | Electronically assisted walkers |
| Xvivo Perfusion | Transplantation Systems |
| Ziemer Ophthalmic Systems | Ophthalmic Systems |
Try aligned elements for free and estimate your time saved.
Enhance Aligned Elements with over 50 available Extensions
Explore our preconfigured extensions, made available to complete your Technical Documentation faster. Extensions are free add-ons to Aligned Elements that can be downloaded and integrated into your Aligned Elements configuration/projects.
We have made these extensions available for download to speed up your work. Use them to save time, increase transparency or improve the quality of your Design History File. Contact our support for more information on how to deploy and use these extensions.
Dive into the rich feature set of Aligned Elements and smart solutions you can use to accelerate your Medical Device Development.
Sign up with us and be the first one to get new resources and blog posts on Best Practices, Lessons Learned and implications of Regulatory updates.
