Quality and Compliance
Consulting on Regulatory Affairs for Manufacturers, Importers, Distributors, including CE certification according MDR EU 2017/745, Technical Documentation, Risk Management according ISO 14971 , etc.
Consulting in Quality Assurance (ISO 13485 Quality Management Systems), providing guidance and maintenance.
Authorized Representative (EC REP) for non-EU manufacturers.
PRRC (Person Responsible for Regulatory Compliance) in accordance with MDR EU 2017/745 Article 15.
In-house or online training in the field of Quallity Assurance and Regulatory Affairs (ISO 13485, MDR and, ISO 14971).
support in development and production ,supplier and subcontractor selection and evaluation.