Lindau Quality AB

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.

Company’s Keywords:

audit, test method validation, iso 13485, project management, usability engineering, iso 14971, fda qsr 820, process validation, design control, quality management systems, iec62304, supplier quality assurance, technical files, mdr, gamp 5, risk management, iso 62366, statistical analysis, software validation, mdd, capa