31:30
Decoding IVDR: Simplifying Software Classification for In Vitro Diagnostics
43:11
Hazard Analysis vs FMEA vs Cyber Security Risks – Examine similarities and differences
49:37
Product Requirements – How to keep them manageable and maintainable
33:38
Verification & Validation Plan – The most boring or the most important document?
05:57
Import Excel data into Aligned Elements using the Aligned Elements Importer
02:39
Electronic Signatures for Documents in Aligned Elements
35:49
7 reasons why Risk Assessments are horrible - and how to tackle them
36:04
Tales of Tangles and Triumphs: Navigating the Pitfalls of Medical Device Development
42:51
Agile and SaMD Development – Pitfalls to Avoid!
46:44
Around the Globe – Med Tech Usability Evaluations in an International Context
02:17
Aligned Elements - Design Control Management for Medical Device Manufacturers
33:02
New in Aligned Elements V3.0
41:24
Unveiling FDA's new Computer Software Assurance: What Lies Beneath the Surface!
34:52
Four things the e-STAR template teaches us about digitalization
37:56
How to avoid Death by Documentation?
03:58
User Management in Aligned Elements
05:27
Download and Upload Templates in Aligned Elements
01:56
License Management
03:16
Mac Computer Sideloading deployment of the Aligned Elements Word Add-In
02:17
Aligned Elements - the Medical Device Design Control and Traceability ALM
36:49
Documenting Cyber Security in Design Controls and Traceability
43:00
Post-Market Surveillance under MDR (IVDR) – not a regulatory burden only
36:43
If everyone comes first - they all come last! Escaping the Risk PMS / Clinical Deadlock
39:21
Why Medical Device Companies are Rubbish at Requirements
12:31
New in Aligned Elements V2.6 Service Pack 1
04:23
Aligned Elements - a Vision on Medical Device Development Documentation
07:33
Synchronizing and Updating Word Reports in Aligned Elements
04:37
Sideloading deployment of the Aligned Elements Word Add-In
05:04
Office 365 Admin Center deployment of the Aligned Elements Word Add-In
06:44
Tricks for Word Reports in Aligned Elements
05:38
Word Reports with Advanced Content in Aligned Elements
06:39
Creating Word Reports in Aligned Elements
09:15
Reviews in Aligned Elements
04:34
Integrating Jira into Aligned Elements
29:14
New in Aligned Elements V2.6
36:57
Risk Identification Techniques for medical devices
48:37
Enter the Dragon - How to get approval for a Medical Device Software in China
35:59
Formative and summative Evaluations – how to identify use problems and take advantage of them
45:38
How to obtain your MDR certificate - Secrets from the Inside by Pontus Gedda
29:25
Traceability - If you don't know where you're going, you are probably not going to get there
46:30
Navigate the risk management maze: Benefit-risk analysis made easy
51:17
Artificial intelligence (AI) Medical Devices on the EU market under MDR – impossible! Or is it?
35:29
How to transform a PMCF study to a business opportunity
22:19
New in Aligned Elements V2.5 SP 6
41:40
Using Task Flow Analysis to create IEC 62366 Use Scenarios
43:20
No Risk, No Fun - More Risk, More Gain!
41:53
SaMD Development is easy, right?
03:47
Issue Management in Aligned Elements
06:23
Preliminary Hazard Analysis in Aligned Elements
03:06
FMEA in Aligned Elements
01:44
Create a Project
08:43
Find your way in Aligned Elements
04:22
Add Attachments in Aligned Elements
03:31
Chapters in Aligned Elements
03:56
Executing Test Cases in Aligned Elements
02:58
Writing Test Cases in Aligned Elements
02:05
Plan a Test Run in Aligned Elements
18:47
New in Aligned Elements V2.5 SP 5
03:09
Missing Traces and Generating Design Controls in Aligned Elements
03:28
Trace Tables in Aligned Elements
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About
Aligned Elements Medical Device ALM delivers worldclass Design Control Management to accelerate your Technical File / Design History File completion.
Built for Medical Device development from the ground up, Aligned Elements supports industry standards regulations such as MDR/IVDR, ISO 13485, ISO 14971 and FDA QSR 820 out-of-the-box.
Aligned Elements provides seamless design control traceability, integrates risk assessment, as well as verification, and validation activities, essential for completing the TD/DHF.
The result is a complete, correct and consistent technical documentation, enabling rapid approvals and an accelerated market access.
We are driven by a singular purpose; to accelerate the development of cutting-edge medical devices while freeing up time for innovation, instead of administration.
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