The International Organization for Standards (ISO) has developed a series of international Quality Assurance standards and quality systems for the medical device industry. In order to market a medical product to the European Community, a CE mark is required that compels medical companies to be ISO 13485 compliant.

Regulatory Specialists, Inc. has assisted a large number of medical companies to become compliant with ISO and EN regulations. Our level of assistance ranges from simple client audits to complete arrangement of ISO and EN Quality Systems within that client's business framework.


  • ISO 13485
  • System Creation
  • Protocol Development
  • Training
  • Internal Audits
  • Maintenance Activities
  • Management Review