Services - Garza MD
Garza MD offers consultancy and assistance in the area of:
Quality Management Systems
- Development and implementation of a QMS
- Optimization and simplification of an existing QMS
- Optimization of specific processes: document control, production, Design & Development, QMS software validation
- Implementation of a new QMS software tool
- Training for better understanding of the QMS in your entire organization
- Advice and coaching for QA and management to improve development and adoption of the QMS in the organization
- Internal auditing
- Gap analysis
CE Marking process
- Setting up, writing and / or structuring Technical Dossiers and Design History Files
- QA and RA advice in the development of new products, from conception to market introduction and post-market activities
- Classification of products, systems and accessories
- Gap analyses for compliance with different standards and regulations
Risk Management
- Facilitating Product Risk Assessment (ISO 14971)
- Facilitating Process Risk Assessment (ISO 9001)
- Setting up a systematic approach for risk management
- Training Risk management for (software) developers, designers and researchers
More information on our training courses.
Requirements and Usability Engineering Process
- Support for the creation of requirements documents
- Support for traceability of requirements, tests, verification and validation (the creation of the Design History File)
- Support in the implementation and application of a lifecycle management software tool (e.g. requirements management)
- Software lifecycle processes in conformance with EN 62304
- Usability Engineering Process (including traceability)
Person Responsible for Regulatory Compliance
- Training on the job for QA Officers
More information on our training courses.
Garza MD provides advice and assistance at different levels of involvement, depending on the needs of the customer. This ranges from a role as a discussion partner upto the actual writing of necessary documents.