Every Grey RA training is fully tailored to the needs of the customer. All trainings are in-company only. Training sessions usually take the form of a workshop with active participation of all attendees. In the table below some examples of recent workshops are listed.
Furthermore, Grey RA cooperates with Allanta to offer a broader range of training and consultancy. Allanta is a team of consultants, specialized in the field of quality, lean, six sigma, safety, environment, sustainability, personal skills and management. Allanta’s mission is to support companies and organizations in the development, implementation and improvement of their business processes, by providing training, consultancy, interim management and coaching. Check out the complete Allanta medical device training program for further information.
| Lean documentation |
| Contents |
Setting up document control structures for development projects. How to keep your documents lean. Document review and release. What is actually required (FDA, CE). Common pitfalls. |
| Target group |
Development engineers, project managers, QA/RA development support staff. |
| Duration |
2 half days |
| Risk Management conform ISO14971 |
| Contents |
Risk management planning. Characteristics and black box risk analysis. How to ensure lean risk management. How to handle complex multilevel designs. Control measure definition, implementation, verification and traceability. Linking with the clinical evaluation. Risk management reporting. Risk Management maintenance. |
| Target group |
Development engineers, project managers, QA/RA staff, complaint managers. |
| Duration |
2 half days |
| Medical Software development conform IEC62304 |
| Contents |
SW development planning. SW risk classification. SW requirements and architecture. What is a software unit. Verification methods. Software configuration management and changes. Documentation expectations. How to show compliance with IEC62304. How to combine IEC62304 with an agile development method. |
| Target group |
Software architects, software engineers, software testers, project managers, QA/RA staff. |
| Duration |
2 half days |
| Compliance with the IEC60601 standards family |
| Contents |
60601-1 family overview, why comply, standard selection, 60601-1 overview, 3rd edition changes, means of protection, internal or external testing, collateral standards, particular standards, lean compliance documentation. |
| Target group |
System architects, mechanical and electrical engineers, verification engineers, project managers, QA/RA staff. |
| Duration |
3 half days |
| Medical device regulations for managers |
| Contents |
Intended markets, worldwide regulations, compliance risks, cost of compliance, cost of noncompliance, organization structure, typical approval times, 3rd party involvement, supplier management. |
| Target group |
Management, purchase managers, quality managers, R&D management. |
| Duration |
2 hours |