David Broecker

• Responsible to upgrade the overall compliance to the requirements of 21 CFR 820 and 803 • In particular upgraded and implement the CAPA System, new Design Control Process, Validations and MDR/Vigilance reporting • Implement the changes required by ISO 13485:2016 • Implemented requirements on clinical evaluation and active post-market surveillance according MEDDEV 2.7/1 Rev. 4 • Gap analysis for the new MDR and initial implementation plan

• Responsible to build and maintain the Global CAPA System • Interim Site Quality Manager Nobel Biocare Yorba Linda, California • Project Quality Manager for implementation of a new ERP System in global manufacturing

• Management Representative • Head of Quality Assurance Department • Responsible for Complaint Handling and Medical Device / Adverse Event Reporting • Maintenance and Handling of the CAPA System • Conduct internal and external GMP Audits • Worldwide registration of Transcutaneous Monitoring Systems and Sensors including Accessories

• Responsible for the technology transfer from Switzerland to the US manufacturing site in Andover, Massachusetts • Change management of the Device Master Records (DMR) • Review and approvals of all manufacturing process changes US manufacturing site in Andover, Massachusetts

• Senior Project Member to establish a new manufacturing site in the US • Responsible for the design and process transfer from Switzerland to the US • Lead to establish new FDA compliant Quality System including requirements of ISO 13485 and Medical Device Directive • Head of Engineering and Development activities in the US

• Responsible for development of Custom Made Devices, Country Specific Medical Devices and Devices for Human and non-Human clinical trials • Vice Head of Development • Worldwide preparation of documents for registration of Implants and it’s accessories including US and Canadian market