Medical Device Quality Management Systems | Annette Callaghan Limited

ISO 13485:2016

ISO 13485:2016 is the harmonised standard for medical device quality systems in the EU and the basis for medical device regulatory compliance in many other countries around the world.

Annette Callaghan has over 30 years’ experience in medical device and pharmaceutical quality management systems. We have extensive experience of the interpretation of, implementation of and compliance with ISO 13485:2016, the medical device directive and the new European medical device regulations.

An effective QMS brings multiple benefits to your organisation. As well as ensuring regulatory compliance, your QMS can also:

Increase your efficiency

Improve your consistency
Improve your products
Improve customer satisfaction
Improve staff morale
Help you make more informed decisions
Ensure that you manage change effectively
Improve your relationship with your suppliers and sub-contractors

And ultimately…

Increase your profitability

We specialise in quality management system creation, implementation and maintenance and can provide you with guidance and support from conception through to certification and beyond….

MDD/MDR Compliance and CE Marking

All medical devices placed on the market in the UK and the EU must comply with the requirements of one of the medical device directives – soon to be the Medical Device Regulations. In most cases, this means that the device must be CE marked, and in all cases, the legal manufacturer must have a technical file for the device. Higher risk medical devices must also be reviewed and approved by a Notified Body before they are placed on the market.

Annette Callaghan Limited can help you navigate the maze of regulations and ensure that you are fully compliant. We are experts in technical file construction and the Notified Body approval processes.