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Regulations and Standards
How requirements are made and used: consensus standards, risk management, quality systems and how to keep practice current as rules change.
How Medical Device Standards Work
What standards are, who writes them and how they become the requirements practice is judged against.
Consensus Standards Explained
How voluntary agreement produces widely used standards, and how to read one without a legal background.
Risk Management for Medical Devices
A structured way to find hazards, judge them and show that they have been controlled.
Keeping Up With Regulatory Change
A routine for noticing that a requirement has moved and acting before an audit does it for you.
Unique Device Identification in Hospital Device Records
A UDI ties inventory, service history and recall notices to one object. What the code contains, who assigns it, and where hospital records usually break down.
Document Control and Retention in Clinical Engineering
Records are the maintenance programme. Which documents to keep, how long to retain them, and how to make the trail easy for an auditor to follow.