Management Systems
ISO 13485 and ISO 9001 designed to ensure quality, traceability and compliance throughout the device life cycle.
Building robust, effective and compliant quality systems
Implementing a management system aligned with international standards is a structural requirement for any organisation operating in regulated sectors.
MediQuasar supports organisations in the design, implementation and maintenance of Quality Management Systems (QMS) compliant with ISO 13485 and ISO 9001, ensuring process traceability, regulatory compliance and continuous improvement.
Our method turns standards, procedures and requirements into practical tools to govern business processes and prepare confidently for audits and inspections.
ISO 13485 implementation
Design, implementation and upgrading of a Quality Management System in line with ISO 13485, the standard specific to medical devices and IVDs. The service includes context analysis, process definition, documentation drafting and alignment with MDR/IVDR technical documentation.
- Context and process analysis
- Tailored QMS design
- Drafting of mandatory and operational procedures
- Integration of risk management (ISO 14971)
- Alignment between QMS and technical documentation
- Preparation for certification and surveillance audits
- Staff training
ISO 9001 implementation
ISO 9001 is the most widely adopted international standard for quality management. MediQuasar supports organisations across sectors in designing, documenting and maintaining the system, focusing it on risk-based thinking, business performance and continuous improvement.
- Mapping of business processes
- Process-based system design
- Identification of risks and opportunities
- Operational documentation (procedures, work instructions)
- Performance indicators and monitoring
- Preparation for certification body audits
- Staff training
HOW WE WORK
1
Initial assessment →
Review of the existing system, processes and regulatory context.
2
QMS design →
Definition of document structure, processes and responsibilities.
3
Operational implementation →
Document drafting, team training and integration with MDR/IVDR.
4
Maintenance and continuous improvement
Audits, KPIs, process optimisation and periodic updates.
Benefits for your organisation
Full traceability
Document and process traceability to reduce risk and errors.
Audit ready
Continuous improvement
Regulatory alignment
Would you like to improve or certify your quality system?
MediQuasar s.r.l.
Via Vittorio Veneto, 11,
41032 Cavezzo MO, Italia
Phone. +39 393 2859 8580
Mail info@mediquasar.it
Vat no. 04162970364