Regulatory Submissions

Medical equipment or medical devices are broadly any product used in healthcare to diagnose a medical condition, prevent illness, promote healing, which is not a medicine. There are literally thousands of different medical devices, from the humble walking stick to the implanted, computer programmed pacemaker.

Governments throughout the world require that medical devices are approved before they can be sold. Approval procedures usually comprise two parts. The first is a record of all the tests and trials which show the device does what it says it does (performs ‘OK’) in a way which minimises risk to the patient, user and others (is ‘safe’). Different countries have different names for this record. The term often used is Technical documentation.

The second part is a Quality system. This comprises all the procedures in the factory to ensure that first and the 1000th device is the same quality as the devices used for the tests and trials, as recorded in the Technical documentation.

Technical documentation

Medical devices embrace almost every technology known to the human race. A number of skills is required to create technical documentation:

  • an understanding of the clinical utility of the device

  • the technologies employed in the medical device

  • guidance on what validation and verification processes are required, including clinical trials (or performance evaluations for in vitro diagnostic medical devices)

  • knowledge and understanding of what the law demands
  • clear file structure

  • last, but not least: writing skills

Priory Analysts will construct the Technical Documentation with the appropriate level of detail for the classification of device being developed. We ensure it captures into a single, identifiable location all the records of product design, development and testing.

Quality system

The extent of the quality system depends on the risk rating of the device. Low risk devices need a very basic system; high risk devices require a system which covers design, manufacture and final inspection. In keeping with a Business Solutions approach to Regulatory Affairs, Priory Analysts works with you to create quality systems that reflect how your business operates, rather than the structure of the regulations. This means that the quality system reflects your language and culture, rather than the terminology of the regulations.

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