SME have typically sufficient experience for their daily business. But sometimes you are running into a lack of capacities, or you want to launch your devices in a country with different regulatory procedures, or you want to enter in to a different device classification.
… we can support you – e.g.:
your last FDA audit ended in a 483 report – now you are in a hurry to work out the observations in time
You do not have sufficient experienced staff to implement requested changes in your Quality Management System according EN ISO13485; e.g.
- Supplier Management
- Risk Management according ENISO 14971
- Complaint Management
- CAPA procedures
- Clinical Evaluation Report
• How to organize the MDR related Post Market Surveillance in an effective manner
• You need to qualify your external suppliers by audits
• You want to go through a Mock Audit according 21 CFR 820 to be best prepared for an upcoming FDA audit
