RA / QA

• Quality management & Management representative

• PRRC (MDR) & EU authorized rep.

• Executive management, strategy

• Gap Analysis

• Set up of KPI’s for QMS processes and business.

• Distributor Management (ref. MDR article 14)

• Quality systems implementation (ISO13485/ QSR part 820)

• Design Control

• Design Dossiers and Technical File for CE marking.

• FDA 510(k) submission

• Communication with authorities

• Preparation and submission of international registrations for medical devices and for IVDs.

• Trained Lead auditor; supplier audits, internal audits

• Risk Management, CAPAs

• Software Validation, Process- and sterilization validation

• Change Control

• ISO 13485 – Medical devices – Quality Management

• ISO 14971 – Medical devices – Risk management

• ISO 10993 – Biological evaluation of medical devices

• ISO 14155: Clinical Investigation – GCP

• IEC 62366-1 Usability

• EU Directives: Medical Device Directive MDD 93/42/EC, in vitro diagnostic directive IVDD 98/79/EC, AIMDD 90/385

• EU regulations: Medical device regulation 2017/745, In vitro diagnostic medical devices 2017/746

• FDA regulations: CFR 21 Part 820, Part 11, 803, 806

• ISO 14155: Clinical Investigation – GCP

• ISO 15223-1 Labelling of medical devices

• ISO 11135 – Sterilization of health-care products ETO

• ISO 11137-1 Sterilization using Gamma Radiation

• ISO 11607-1; -2 Packaging