European Union
SRS, Inc. provides Regulatory Affairs, Regulatory Compliance and Quality Assurance services to European requirements. These services include:
- Technical Files and Design Dossiers
- QMS and Regulatory training- ISO9001:08, ENISO 13485:12, MDD
- Internal and Supplier Audits
- QMS development
- Facility assessments for Notified Body certification audits
- Company representation during regulatory inspections
- Regulatory research
- Response to regulatory actions such as FDA Warning Letters and FDA 483
- Recall Management
- Technical file preparation