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 […]
Failure Mode and Effects Analysis (FMEA) Software Regardless of the industry, problems and defects are always expensive, and there are many high-profile examples of manufacturers, software developers, and service providers that were forced to close their doors because they were not able to detect problems and defects early enough. Those who implement a reliable method […]
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Introduction In today’s globalized market, regulatory compliance is no longer a localized hurdle; it is a complex, moving target. From the EU’s Medical Device Regulation (MDR) to the Automotive Cyber Security (ISO 21434) and environmental mandates like RoHS/REACH, the cost of non-compliance is catastrophic—ranging from massive fines and product recalls to total market exclusion. Regulatory […]
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Introduction In the digital era, it is easy to forget that every software instruction eventually runs on a physical substrate. Unlike software, hardware is subject to the laws of physics: it wears out, it overheats, and it can break under mechanical stress. Risk Management for Hardware is the systematic process of identifying and mitigating the […]
Introduction For decades, cybersecurity was perceived as a “software problem.” However, as products become more connected and autonomous, the physical layer—the hardware—has become a prime target for sophisticated attackers. Hardware Security is the practice of protecting the physical components of a system from malicious attacks, unauthorized access, and tampering. In a Product Lifecycle Management (PLM) […]
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 […]
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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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 […]
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 […]
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) […]
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 […]
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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