Aligned AG

Aligned AG

Category: Content
Type: Blog Article

Generated 1 week ago

New blog articles detected

  • Aligned Elements V2.4 released

    {fastsocialshare} What's New We are proud to have our customers bring you Aligned Elements 2.4. This release includes some of the top voted features requested by the Aligned Elements user community. We hope you enjoy them! Managing Test Runs Plan and Manage Verification and Validation Tests in Test Runs.Get full overview of Test development and immediate feedback on Test Progression. Parallel Tes...

Aligned AG

Category: Content
Type: Blog Article

Generated 1 month ago

New blog articles detected

  • The inside story of an MDSAP audit

    {fastsocialshare} One audit to rule them all.  Sounds good, doesn't it? If you have spent a lot of time in audits lately, then you are certainly not alone. More and more company resources are devoted to a continuous string of auditing activities. The Medical Device Single Audit Program is an initiative by the IMDRF intended to curb the audit avalanch.   But does the promise hold? Or is it too goo...

Aligned AG

Category: Content
Type: Blog Article

Generated 1 month ago

New blog articles detected

  • Questions about MedTech standards? Get the answers straight from the source!

    Our friends at Qadvis has grown steadily over the last couple of years and this is no wonder. These guys are co-authors of many of the standards you use today. If you have questions about ISO 13485, IEC 62304, IEC 80001-1 or IEC 60601-1, who would be better to ask than the person who actually penned it?  I can highly recommend their services and advice. Just recently the Qadvis Team put together ...

Aligned AG

Category: Content
Type: Blog Article

Generated 1 month ago

New blog articles detected

  • Start your road to efficient medical device documentation here!

    {fastsocialshare} You spend too much time and money on documentation. Agreed? Good. So what is your plan? The regulations of the medical device industry requires us to produce a pretty hefty chunk of documentation to show that the device is safe and efficient. If the documentation is not compliant, then it does not matter how safe, secure and performant the device itself it. Therefore, the documen...

  • How to document a powered Exoskeleton according to the FDA

    {fastsocialshare} A few years ago we could read articles claiming "Exoskeletons will one day replace wheelchairs". That the FDA regulates these kind of devices is a clear sign that they are about to enter the mass market. Miniaturization of electronics, a steep drop in manufacturing costs of mechatronic parts, increased computational power, more powerful batteries. A number of recent technical dev...

  • Meet us at Med Conf 2016 in München 25-28 October

    {fastsocialshare} We are participating in the Med Conf 2016 25-28 October with our lecture "Death by Documentation - how to identify documentation inefficiencies in your medical device development process" If you ar interested in how to assess the documentation process in order to find process inefficiencies in your own company, then this one is for you! The lecture is held by our CEO Anders Emmer...

Aligned AG

Category: Content
Type: Blog Article

Generated 5 months ago

New blog articles detected

  • Med Tech Industry Study: "Quality and documentation requirements" ranks as top challenge

    {fastsocialshare} The Swiss Medtech Industry Sector study surveyed more than 340 medical device companies in this year’s SMTI industry study, uncovering the current opinions and views in the Swiss Med tech market. The study claims that "the ever increasing quality and documentation requirements" and the difficulty to "preserve innovative capacity" are the primary challenges to remain competitive i...

Aligned AG

Category: Content
Type: Blog Article

Generated 6 months ago

New blog articles detected

  • Announcing the 2016 Medical Device Documentation Survey!

    {fastsocialshare} The 2016 "Documentation Trends and Insights in Medical Device Documentation" survey is live! Are you alone in experiencing challenges when it comes to Medical Device Documentation? Or is what you feel shared by the industry? We invite you as a Medical Device professional to share your thoughts on the state of documentation practices by participating in this survey. The survey wi...

Aligned AG

Category: Content
Type: Blog Article

Generated 7 months ago

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