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Product News

IEC 62304 Checklist for Software Audits

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The hidden treasure in your Technical File

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

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Free Online Medical Device Development Seminar - Sharpen your Skills 2021

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Do you have an Issue with that?

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Webinar: New in Aligned Elements V2.5 SP 4

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Connecting Aligned Elements to Sparx Systems Enterprise Architect

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

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Aligned Elements V2.5 SP 4 released

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

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5 points when evaluating an ALM for Medical Device Development

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The IMDRF terminologies - a common risk language

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An author of IEC 62304 revisits the standard after 14 years

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Identifying Risks using ISO 14971:2012 Annex C

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Risk vs Benefit => Residual

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

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Aligned at MedConf 2020 21-23 October

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

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Aligned Elements V2.5 SP 3 released

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Videos and presentations from Sharpen Your Skills 2020

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Reaping the Benefits of Agile Testing in Medical Device Development

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Aligned Elements V2.5 SP 2 released

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Aligned Elements as Hosted Solution

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Register for "Sharpen Your Skills 2020" - Free Virtual Medical Device Development Seminar

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Escape the Office

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New: A IEC 60601-1 Risk Assessment Checklist

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Accelerating the Conformity Assessment process

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Hey Startup! Meet us at the Regulatory Journey event in Schlieren, Jan 16th

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Reducing the Design Documentation Effort with 80%

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Speed up your Computer Software Validation activities

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