If you do not have a quality management system in place, all of our consultants are ISO 13485:2016 lead auditor trained. We have a wealth of experience in putting Quality Systems in place for companies.
There are mandatory procedures that must be part of your Quality Management System (QMS) – the ISO 13485 implementation as standard defines these processes and is the recognised gold standard for quality in the medical device industry.
We would be happy to perform an overview of what would be required and included for your Quality Management System, tailoring to your organisational needs. Our team will help to ensure that all of the ISO 13485 implementation requirements are addressed in your QMS.
We can also help you select a certification body and manage the audit process for you, so that you have one less thing to worry about.