Brammer Engineering has the qualification certified by the notified body BSI to act as internal auditor for medical quality management system (QMS) according to ISO 13485. ISO 13485 is a central QMS for medical devices as well as In-Vitro diagnostics which obliges the various economic operators to implement different regulatory requirements. With the following services Brammer Engineering supports you in questions concerning medical devices, personal protective equipment (PPE) and in vitro diagnostic devices (IVD):
- Review and presentation of regulatory requirements required for the various economic operators.
- Support in the conformity assessment process for medical devices, IVDs and PPE
- Establishment of a QMS according to ISO 13485 incl. necessary documentation
- Conformity checking for medical devices, PPE and IVDs according to the valid regulatory requirements of the EU
- Training of personnel on medical devices, PPE and IVDs regulatory requirements
- Preparation of all necessary regulatory documents for individual economic operators