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.
https://t.co/fA5scB6KQa
You are spending too much time on your technical documentation. Most of us do. But does it have to be this way?
https://t.co/gBElwXJafA
#medicaldevices#technicalfile
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. https://t.co/nQ8OTBWwLz #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!
https://t.co/PhkBpzEeuT
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!
https://t.co/yV19gVZHEO
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!
https://t.co/N03m28GDlL
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!
https://t.co/hAtcE0CalB
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
https://t.co/kZFsQCvi1e
How can ISO 14971:2012 Annex C and Aligned Elements kick start your Risk Identification? Find out here...
https://t.co/b1TWhKLmoh
#ISO14971#RiskManagement
Benefit-Risk analysis in ISO 14971 Medical Device Development - how and where to document it properly!
https://t.co/j9OCa3jqTO
#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.
https://t.co/Ml2UnfcKLb
#IEC62304#LegacySoftware#SOUP#MedicalDevice#AlignedElements
Did you know about these #UserNeed writing tips? If you develop medical devices, they might save you some time and tears. #fda#designcontrols https://t.co/OvVylXh17d
We are running the "Sharpen Your Skills" - seminar again with the best speakers to date! Check out the program! https://t.co/IzfTithkjo https://t.co/6jhhG23uSi