Want to demonstrate compliance with IEC 62304 by easily leverage your existing documents and design controls? In Aligned Elements you can now user the IEC 62304 Checklist for audits.
aligned.ch/blog/product-news…
You are spending too much time on your technical documentation. Most of us do. But does it have to be this way?
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#medicaldevices #technicalfile
Don't miss out on "Mindset Impossible?" today on the Digital Chameleon show. Get your information here: ow.ly/IUvk50DVVJS
Join us on April 13th for a Free Medical Device Online Seminar. We have invited the best experts in the industry to help you develop faster and more efficient. ow.ly/F5gc50DSCX0 #medicaldevice #MDR #Eudamed #SoftwareRisks #UX #IEC62366
Are you considering using an Issue tracker like Jira or Azure Dev-Ops for your Design Control documentation? Think again! Read more about how Aligned Elements integrates with a range of Issue trackers that allows you to get the best of both worlds!
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Integrating SVN in Aligned Elements! Refer to check-ins and source code.
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#alignedelements #medicaldevices
I am glad to announce the release of Aligned Elements V2.5 SP 4.
A big thank you to the relentless effort put in by our R&D team. Also, their magic wouldn't be possible without the constructive, and honest feedback from our customers. Cudos!
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Is 2021 the year for switching from a paper based documentation system to a medical device ALM? Does it sound scary? Use this guide to get control over the acquisition process and get the best ALM for your organisation!
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Risk assessments are hard to read, write and review. Using a common terminology might help. And if you didn't know: there IS a common risk terminology available. Read more here!
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An author of IEC 62304 re-visits the standard 14 years after its initial release. What does he have to say? Has it aged well? Find out here!
#iec62304 #medicaldevices
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How can ISO 14971:2012 Annex C and Aligned Elements kick start your Risk Identification? Find out here...
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#ISO14971 #RiskManagement
Benefit-Risk analysis in ISO 14971 Medical Device Development - how and where to document it properly!
aligned.ch/blog/53-tips-tric…
#14971 #riskmanagement #MDR
IEC 62304 and existing software. Learn more about your options on how to bring in Legacy Software, SOUP:s and prototypes into the fold of IEC 62304 in this article.
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#IEC62304 #LegacySoftware #SOUP #MedicalDevice #AlignedElements
Last chance to register! Deep MDR knowledge from top speakers! Reserve your seat today! #mdr #medicaldevice lnkd.in/dZ9RUeW
ALIGNED AG retweeted
Leitfaden IT-Sicherheit / Guideline IT Security johner-institut.de/blog/john…
5 tips on how to write better risk assessments! bit.ly/2zrKzcu #iso14971 #riskmanagement #MedicalDevices
Did you know about these #UserNeed writing tips? If you develop medical devices, they might save you some time and tears. #fda #designcontrols bit.ly/2PhsQ1e
We are running the "Sharpen Your Skills" - seminar again with the best speakers to date! Check out the program! lnkd.in/dxr_BPW lnkd.in/dwrhgvQ
How to perform Medical Device Testing in Aligned Elements. lnkd.in/gH_2yvc


