Back to content We furthermore mitigate risks associated with quality and safety by Biological Safety Evaluation and use ISO10993 as a guiding standard. We evaluate materials in skin contact in ac- cordance with the standard and when necessary, we perform animal testing according to ISO10993-10 while evaluating whether chemical extraction and characterisation is deemed sufficient instead. These tests are conducted by external part - ners. our quality objectives, and how they should be measured. Quality objectives includes product quality as measured trough Quality Samples Program (QSP), complaints, vigilance and quality of delivery. Additionally, we have objectives related to other areas, such as follow-ups on project goals, supplier monitoring, delivery performance, employee trainings, launch quality and continuous improvement of the QMS to ensure efficiency and support a fast-growing organisation. Back to chapter 4.1.2 Hearing Implants Bone-anchored hearing systems Within our BAHS business, we apply a risk-based approach to all activities and our Quality Management System (QMS) defines policies, procedures, and practices for analysing, evaluating, and controlling product risk throughout product realisation. Relevant general standards, directives, regulatory requirements and common specifications applicable to our QMS are identified alongside relevant product specific stan - dards that are then implemented in the product requirements. We perform clinical and risk management evaluations, consid- ering applicable state-of-the-art treatments within the indica- tion for use, and we identify requirements for new markets and document these. The Hearing Implants management team have the overall re- sponsibility for all BAHS-related products and services provid- ed by us. Executive Management is responsible for supervising and reviewing efficiency of the QMS as well as to develop the system and methods for working with quality. The quality system is based on EN ISO 13485:2016, and the requirements from LVFS 2003:11, including amendments and corresponding requirements in Council Directive MDD93/42/ EEC of 14 June 1993 concerning medical devices including amendments, and Regulation (EU) 2017/745 of the European parliament and of the council of 5 April 2017, on medical de- vices. Conformity is assessed according to Article 52, for class I follow Annex II and III and for class >1 Annex I with applicable sections. Based on learnings from our previous generation products, as received through the complaint system and return investiga- tions, we continuously implement improvements in our design. Also, learnings from other business areas of the Demant Group are implemented by leveraging on synergies in development and testing. The quality department initiates an investigation with the priority as required by the seriousness of the incident and corresponding responsibilities are assigned. In collaboration with competent personnel, a risk assessment of the situation is made. The risk assessment determines whether an incident has, or could have, occurred, and whether the malfunction is related to all articles produced, a production batch or a single article. Then, necessary actions are identified, and responsibil - ity is assigned. To secure that we fulfil our quality policy, quality reports are made covering all functions and areas of the business. These are reviewed at least twice a year and reported on manage- ment reviews meeting where we make further decisions about Demant ∙ Sustainability Report 2021 200
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