Aligned AG - Blog | Aligned Elements - the Medical Device ALM

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Meet us at the Swiss Medtech Expo in Luzern!

IEC 62304:2021 is dead. Long live IEC 62304!

Design Controls according to IEC 82304

Webinar: New in Aligned Elements V2.5 SP 5

Aligned Elements V2.5 SP 5 released

Software Hazard Identification based on IEC 80002-1 Annex B

Video Recordings from Sharpen Your Skills 2021

IEC 62304 Checklist for Software Audits

The hidden treasure in your Technical File

Listen to Aligned's CEO Anders Emmerich on "Mindset Impossible?"

Free Online Medical Device Development Seminar - Sharpen your Skills 2021

Do you have an Issue with that?

Webinar: New in Aligned Elements V2.5 SP 4

Connecting Aligned Elements to Sparx Systems Enterprise Architect

Using Aligned Elements to trace to Source Code in a Subversion Repository

Aligned Elements V2.5 SP 4 released

Delayed but not forgotten – MDR/IVDR should make you work smarter

5 points when evaluating an ALM for Medical Device Development

The IMDRF terminologies - a common risk language

An author of IEC 62304 revisits the standard after 14 years

Identifying Risks using ISO 14971:2012 Annex C

Risk vs Benefit => Residual

Using existing software when developing a medical device; a gift from the gods or a Trojan horse?

Aligned at MedConf 2020 21-23 October

Medical Device Validation: what is it? Wait! Are there several kinds?

Aligned Elements V2.5 SP 3 released

Videos and presentations from Sharpen Your Skills 2020

Reaping the Benefits of Agile Testing in Medical Device Development

Aligned Elements V2.5 SP 2 released

Aligned Elements as Hosted Solution

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