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What Is Impact Analysis?   

Impact analysis

Every decision has consequences. When leaders don’t think them through, the results can be downright devastating. By focusing on the unexpected, often negative, implications of decisions, impact analysis can identify the potential consequences of a change and help organizations make informed decisions This article explains what impact analysis is, how it can be applied in […]

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What Is an Electrical Risk Assessment?

Introduction As products become increasingly “smart” and electrified—from electric vehicles to wearable medical devices—the complexity of their electrical systems grows. An Electrical Risk Assessment (ERA) is a systematic process used to identify, evaluate, and control hazards associated with electrical energy. In a Product Lifecycle Management (PLM) framework, an ERA is not a one-time event but […]

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Risk & Safety Analysis for Mechanical Engineering

Introduction In mechanical engineering, risk management is a matter of physical integrity. Whether designing an industrial turbine, a medical implant, or an automotive chassis, engineers must account for forces that are often invisible until a failure occurs: stress, fatigue, thermal expansion, and vibration. Risk & Safety Analysis for Mechanical Engineering within a PLM context involves […]

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Risk Management in PLM

Introduction Every new product carries inherent risks—from technical failure and safety hazards to budget overruns and supply chain disruptions. In the past, risk management was often a “post-mortem” or a late-stage activity. However, in the era of smart, connected, and safety-critical products, this approach is no longer sustainable. Risk Management in PLM is the systematic […]

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What is Conformance Testing

Introduction In an increasingly connected world, no product exists in a vacuum. Whether it’s a medical device communicating with a hospital network, a sensor joining an Industrial IoT (IIoT) ecosystem, or a component fitting into a complex aerospace assembly, products must adhere to precise technical “rules.” Conformance Testing is the process of verifying that a […]

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What is Certification Testing

Introduction In the final stages of Product Lifecycle Management (PLM), there is a definitive boundary between a product that is “ready” and a product that is “authorized.” Certification Testing is the formal, often third-party, validation process required to obtain an official certificate of conformity. Whether it is an airworthiness certificate from the FAA, a 510(k) […]

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What is Compliance Testing

Introduction In industries where safety is paramount, a product is not “finished” when it works; it is finished when it is proven to be compliant. Compliance Testing is the rigorous process of verifying that a product meets the specific requirements of external regulatory bodies, industry standards, and legal mandates. Unlike standard functional testing, which focuses […]

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Design Verification and Design Validation in Product Lifecycle

Introduction In the complex journey of bringing a product to market, two fundamental questions must be answered: “Did we build the product right?” and “Did we build the right product?” These questions represent Design Verification and Design Validation, respectively. Within a Product Lifecycle Management (PLM) framework, V&V are not mere checkboxes at the end of […]

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Automation of Mechanical Testing

Introduction In the lifecycle of any physical product—from a surgical instrument to an aircraft wing—mechanical integrity is non-negotiable. Traditionally, mechanical testing has been the most “analog” part of the engineering process, involving heavy machinery, manual strain gauge placements, and destructive tests that required constant human supervision. However, as product complexity increases and time-to-market shrinks, manual […]

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Automated Hardware Testing

Introduction In the development of complex systems—from medical devices to electric vehicles—the hardware remains the ultimate “reality check.” Traditionally, hardware testing has been a manual, labor-intensive process involving physical rigs, manual measurements, and handwritten logs. This manual approach creates a significant bottleneck in the Product Lifecycle Management (PLM) process, often delaying product launches and leaving […]

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