Regulatory Services

• Consulting advice and regulatory strategies for start ups

• FDA Registrations and Listing

• US 510(k) submissions

• EU Technical File preparation for CE marking

• Interim Management

• Design History File Preparation

• Independent Reviewer

• Risk Management

Quality Services

• FDA Inspection Preparation

• FDA QMSR updates

• ISO 13485 implementation

• Risk Management Systems and File Maintenance

• Quality System Development

• Supply Chain Audits

• Internal Audits

• Customised Training

• Due Diligence Preparation & Assessments