When requirements start to become fragmented... The larger and more complex a medical device development project becomes, the more information is generated. Requirements are documented in documents, technical decisions are recorded elsewhere, and tests are documented in separate files. ...
02/05/2026
What difference can a CPR feedback system make to cardiopulmonary resuscitation? In the event of cardiac arrest, the transport of oxygen to the body's cells stops immediately, leading to irreversible damage. Cell death begins after just three minutes. This process ...
12/01/2025
I frequently read articles that cite IEC 60601-1-2 as the sole EMC requirement for medical devices. However, anyone who believes that IEC 60601-1-2 covers all EMC requirements for medical devices may be overlooking something. Here's why. When is IEC ...
05/27/2024
Writing requirements is an integral part of every product development. Only when you know what the product is supposed to do can you design it accordingly and ultimately test it. But time and again, I see specifications that simply don't ...
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