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