Regulatory Compliance

Meridian Line Systems can make your Quality Management System work with you not against you.

Meridian Line Systems has overseen the implementation and use of several Quality Management Systems (QMS) and approaches including:
+ ISO 27001 (information security),
+ ISO 13485 (medical device specific QMS),
+ and IEC 62304 (a guidance for the development of software used in medical devices)
as well as ensured that general requirements such as GDPR are adhered to.

If a QMS is required, then it is important that it is designed and implemented correctly and pragmatically. If a QMS is too unwieldy it will be bypassed meaning that the organisation will be pursuing a partially formal, partially informal set of processes in parallel, duplicating workload and frustrating progress.

By being sensitive to the requirements of the compliance regime as well as the real world impact of it use, the QMS that we implement will generate the evidence required as a by product of being the ‘natural’ way to work.

Meridian Line Systems can ensure that a Quality Management System is implemented for your organisation that supports rather than obstructs your strategy.

Once the QMS has been implemented it needs to be operated so as to deliver the product and any records required. For medical devices, these records take the form of a technical file, tailored for the region and regulatory authority that will authorise the device (CE marking for the EU, 510K for the US, UKCA for the UK).

Meridian Line Systems can work with you to ensure that a high quality complete technical file is prepared and where necessary submitted for accreditation (eg CE marking Class II).