About ISO 13485 / CE / MDD/ MDR
Strategy for regulatory compliance – EU
Grouleff Medical design and manufacture medical devices class I, according to both the Medical Device Directive (MDD), and the Medical Device Regulation (MDR)
We have implemented a Quality management system according to ISO 13485.
Our Quality management system is compliant with the requirements in the Medical Device Regulation and cover design and development, supplier evaluation and approval, production planning, production, test and verification, traceability, marked feedback – Post marked surveillance, handling nonconformity’s and procedures for recall and information to regulatory authorities.
To ensure the effectiveness – there is an ongoing follow up on non-conformity´s, improvement activities, and our quality objectives. Each year Management review meeting is conducted, to ensure that the system is effective, to evaluate the need for special focus areas, new or changed procedures or changes in requirements from the marked. Legislations or standards.
We follow good manufacturing praxis and have procedures for calibration of measurement equipment.
Medical device file – declaration of conformity.
Before signing a declaration of conformity, Grouleff Medical fulfill the requirements in the medical device legislation regarding Technical documentation, - we conduct risk evaluation after the EN 14971 standard and ensure that risks are as low as possible and that the overall remaining risk is acceptable. Information about remaining risks is informed in the Instruction for use that follow the device, as well as information´s about correct and safe use and maintenance are listed in the Instruction for use.
Before Declaration of conformity is released and signed, there is an internal review of the documentation that is made, tests, verification, instruction for use, classification, risk analyses and other documents in the Technical documentation. Review is performed by a team containing different competences and knowledge. Declaration of conformity is signed by the Grouleff Medical CEO.
Each device is tested in accordance with specific test requirements, before it leaves the factory.
Our own test engineer performs the test and sign the test report.
Grouleff Medical is in some cases, a sub supplier to medical device manufactures. We design the components and devices, make design specifications, source, manufact the component and device, and perform test and verification. All tasks are performed in compliance with the requirements from the customer / manufacturer.
Grouleff Medical Quality policy
Thomas Iversen CEO