ISO 13485
ISO 13485 Consultancy & Training
The team at Lorit Consultancy has many years of experience with quality management systems for medical devices and is therefore your competent partner for the application of ISO 13485 – Quality management systems – Requirements for regulatory purposes.
About ISO 13485
ISO 13485 regulates the basic requirements for a quality management system for manufacturers of medical devices and other medical technology stakeholders.
The requirements include management responsibility, resource management, product realization and service provision, and measurement, analysis, and improvement.
ISO 13485 relation to other standards
ISO 13485 extends the requirements of ISO 9001 for a quality management system to include the specific requirements for medical devices.
The requirements of ISO 13485 partially overlap with the requirements of IEC 62304 Medical device software – software life cycle processes and the IEC 60601 family of standards. ISO 13485 supports the requirements of IEC 62304 and the IEC 60601 family of standards, for example in the product manufacturing process, in the change management process and the CAPA process. ISO TR 20416 is used to support the required post-market-surveillance process.
The required internal audits are successfully implemented by complying with the specifications in ISO 19011.
Our services
Consultancy & Support:
- Quality management manual, quality policy and quality objectives
- Responsibility of the management
- Resource Management
- Product realization and service provision
- Measurement, analysis and improvement
- Implementation and documentation of the processes required for the quality management system
- Medical device file
- Control of documents and records
- Qualification of software tools
- Validation of software tools
- Applicable regulatory requirements
- Post-market- surveillance
- Implementation of external audits and support for internal audits
Trainings:
We offer (online) training courses that can be customized to meet your needs in terms of date, format and content. In our ISO 13485 course, we introduce you to the basics of the standard using work examples, team exercises, and our industry knowledge and experience.
You will get an overview of the responsibility of management and the resource management. Processes for product realization and service provision are also considered. The course introduces you to processes for measurement, analysis, and improvement.
You will learn the differences to ISO 9001 and how to meet the requirements of the Medical Devices Regulation (MDR) by implementing ISO 13485. The course also provides information on quality management systems in other countries, such as the USA (21 CFR 820), and compares to quality management systems in other safety-related industries, such as the automotive industry. The course covers validation of software tools, planning and conducting internal audits according to ISO 19011, and planning and conducting post-market-surveillance.
The course also introduces the Medical Device Single Audit Program (MDSAP). With the MDSAP, compliance with the regulatory requirements of the USA, Brazil, Japan, Australia and Canada can be proven with a certification process.
