Decus has a consistent track record of successful FDA and other regulatory agency outcomes. We have helped multiple clients in the following areas:

• Strategic planning
• Pre-submission meetings with FDA
• Investigational plans and clinical protocols
• 510(k) submissions
• PMA submissions
• CE Technical File submissions
• Canadian Submissions
• FDA export approvals
• Preparation and guidance for FDA, Notified Body and CA-FDB inspections
• Registration and Listing
• Complaint Handling

Quality of your design documentation is a critical piece of any regulatory submission. Decus can help to prepare or review design documentation.  We can guide you with best practices and project management to generate high quality documentation needed for FDA submissions:

• Design History File
• Device Master Record
• Risk Management File
• Usability Engineering Process
• Plan and conduct Usability validation studies

Decus has particularly strong expertise in software development and software quality, especially for software-reliant electro-mechanical devices and stand alone software medical devices. We can supplement your team by providing the following services:

• Conduct IEC 62304 compliance assessments
• Develop software procedures and templatesCreate procedures and templates for software tool lifecycle management and 21 CFR 11 compliance
• Create procedures and templates for software tool lifecycle management and 21 CFR 11 compliance
• Write verification and validation plans and procedures
• Create and execute software tool validation processes
• Participate in design reviews
• Review DHF documents for compliance with regulations and standards
• Ensure software risk management compliance with ISO 14791 and IEC 62304

Decus can help you prepare and execute an entire clinical trial or we can support your team to perform specific tasks. We have designed and conducted multi-site trials and bench studies for Class II and Class III devices.  Our study experiences include multi-national multi-site studies that support US and International regulatory approvals, as well as efficient single site protocols for development purposes. Our strengths include:

• Study and protocol design
• Case Report Form and eCRF design
• Clinical operations
  • Planning and Budgeting
  • Site selection
  • Study Project Management

• Clinical study file management
• Data management
• Clinical trial monitoring
• Validation of clinical computerized systems
• Clinical study reports
• Clinical evaluation reports for CE technical files

Decus has helped many clients establish and/or improve their quality systems, enabling clients to pass FDA inspections, pass California state inspections, and obtain CE mark for their devices. Decus can help companies to:

• Establish Quality System processes or improve existing procedures to maintain compliance to:
  • FDA regulations
    • 21 CFR 820 – Quality Systems
    • 21 CFR 803, 806 – Medical Device Reporting and Corrections
    • 21 CFR 812 – Investigational Device Exemptions
    • 21 CFR 11 – Electronic Records and Electronic Signatures
  • Medical Device Directive
    • ISO 13485 – Quality System
    • IEC 62304 – Software Medical Device Development
    • ISO 14791 – Risk Management
    • IEC 62366 – Human Factors / Usability Engineering

• Conduct internal audits / gap analyses
• Conduct supplier audits
• Execute quality system processes as needed (e.g. document control, complaint processing)
• Set up and validate software tools needed for quality system
• Help prepare or run FDA, California state, and Notified Body Inspections
• Generate and manage CAPAs related to inspection /audit findings
• Conduct Quality System improvement projects