Medical Devices

Partner with our team of regulatory experts for excellence in quality, compliance and experience in combination Medical Device QMS management.
Services include:

• Combination Medical Device QMS set-up and management

• ISO 13485 Medical Devices Auditing

• ISO 13485 & ISO 14971 Supply chain set-up and management

• ISO 13485 Inspection Readiness

• Technical File Creation

• Ongoing Quality Management (all classes) and combination Products