ISO 13485 : 2016 Consulting

Our Consultants have extensive experience in developing and implementing ISO 13485 : 2016 Quality Management Systems in medical industries. We’ve refined our services through years of hands-on application and we continue to improve our offerings to ensure our customers receive the highest quality service available.

Based on your organization’s specific needs and objectives, we can provide you with the following consultant assistance:

• Quality Management System (QMS) planning, development, documentation and implementation assistance
• System maintenance and on-going support
• Internal Audits and Management Reviews
• Employee training and skills development
• Certification audit, surveillance audit and re-certification support
• Data collection, analysis and reporting
• Process and productivity improvement
• Supplier surveillances; inspections; supply chain audits
• Other outsourced Quality support