Moritz Hoyer

Providing consultant services and hands on support in the QM and RA field of medical devices: - Establishing, maintaining, optimizing QM-Systems in compliance with ISO 13485 and applicable national regulations - Internal & Supplier Audits - Regulatory support during development projects - Support for creating technical documentation - Support for complying with several technical standards - Support for V&V strategy Management: - Managing the South German Team - Business development

- Maintaining, development of a Quality Management System according to EN ISO 13485. - Lead the company through several external audits by the notified body - Support the development department to create a technical documentation - Regulatory support for the development team - Complaint handling

- Establiscing, maintaining and optimize of the QMS in compliance with ISO 13485 and other national requirements - Leading the company through several audits by NBs and CAs - Creating and maintaining the technical documentation - Perform several international product registrations - RA support for the development team - Complaint handling - Leading the production

- Support for software verification and validation - Writing software specification - Performance test for some software features - writing diploma thesis: Creating concepts to improve the femur navigation during hip replacement surgery.