Services by Topic

Europe

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, ISO13485:03, 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

Services by Location