Lindau Quality AB perform consultant services within the Medical Device industry. Always with focus on the requirements - and with a risk based and pragmatic approach. Services include: * Establishing, updating, auditing and optimizing Quality Management Systems according to EN ISO 13485:2016, including all regulatory requirements and applicable standards. Includes support with certification activities and handling of audit deviations. *Ensure that Design & Development is performed according to Design Control requirements, including mandatory elements such as Essential Requirements, Usability Engineering, Risk Management etc. Establishment/updates, auditing and optimizing of the Technical File for CE-marking. * Ensure that the product is manufactured correctly, regardless if it is by the own organization or others. Support with Supplier Qualification (including Quality Agreements, Supplier Audits/Controls, Process Validation (including Software Validation) and establishment of tools to maintain a validated state. *Any support with Quality related projects (as independent support, project leader or project member), managing Critical Non-Conformities, Corrective & Preventive Actions, Data Analysis, Validations, Internal Audits etc.
