- Technical Documentation: Leading the development and updates of technical files in accordance with EU MDR, including the coordination of verification and validation routines such as clinical evaluation, biological evaluation, software validation, EMI and usability studies.- Quality Assurance and Compliance: Overseeing the development and implementation of QMS under ISO 13485 for clients and development and implementation of internal routines to ensure compliance with ISO 9001.- Audit Coordination: Managing and coordinating internal audits, supplier audits, and mock inspections in collaboration with partner auditors.

- Coordination of Product Development under ISO 13485- Coordination of Supplier Audit- Implementation of QMS with a focus on ISO 13485- Conducting Design and Usability Risk Analysis in accordance with ISO 14971- Development of VBA Tools- Project Management- Document Control- Technical File Preparation- FDA Pre-sub Documentation Preparation

- ISO 13485 QMS training, procedure development, and follow-up for manufacturers- Development and coordination of medical device risk analysis according to ISO 14971- Assistance with and monitoring of regulatory affairs for medical devices- Preparation of technical documentation for medical devices- Automation of procedure creation using VBA tools development

- ISO 13485 QMS Procedures Training and Development- ISO 14971 Risk Management Activities- Technical Documentation preparation for Medical Devices under MDR 2017/745- Preparation of spreadsheets and development of support documents

• Regularization of the Company in accordance with the Health Surveillance Requirements.• ISO 13485: 2016 and Quality Management System Audit - Internal Auditor.• Logistics Applied to Medical Devices.• Medical Device Projects.• Sanitary Product Classification.• Clinical Research with Medical Devices.• Health Risk Management.• Implantable Medical Device Registry and Unified Tracking System.• Registration of Electromedical Equipment.• Techno Surveillance• Notification of Medical Devices.Check my Website.

• Team management – 5 people from the administrative and commercial department• Cost Reduction and Financial Balance• Sales Consultancy, Sales and Telemarketing Training

Capture and sale of national and imported vehicles, web service, telephone and personnel.Assisting in the approval of financing, consortium partners and closings.Data acquisition and maintenance of customer base.

• Development of Supervisory System • Management of spreadsheets of sensors, analog and digital inputs and outputs• Implementation of supervisory system with Ethernet protocol• Layout and design of Photoshop images• Organization and registration in a constructive system of project files