Management Systems according to ISO13485: 2016, EU - MDD/MDR, 21CFR820, ISO9001: 2015, ISO27001, ISO14001 & ISO45001: 2018 (OHSAS18001)

• Establishment and implementation of QA, Regulatory, Environmental and Safety programs

• Documentation of work processes in procedures and work instructions

• Organizational measurements - KPI

• Internal quality audits

• Preparing and representing the organization toward third party quality audits

• Risk management programs: mapping, evaluation, provision of medicines and their timing

• Quality management surveys

• Management of corrective and preventive actions – CAPA

• Training

• Regulations and standards - mapping the regulations and devices that the product under development is required to comply with

• Supporting the Project Manager in its implementation - PMO

• Development folder management (DHF)

• Risk Management (FMEA)

• Product verification strategy

• DOE – Design of Experiment

• Reliability calculations

• Support for environmental experiments

• Training

• Engineering change management

• Documentation change management

• Device Master Records

• Transition from development to production: Preparation of work instructions for production and testing

• Adverse events investigation

• Safety tests support (IEC60601, UL, etc.)

• Validation of production processes - Production Process Validation

• Improving production processes 6Sigma / 5S

• Corrective and Preventive Actions - CAPA

• Supplier quality: evaluation, control, and handling of SCAR complaints

• Statistical analysis

• Training