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

• Strategic planning/ regulatory assessmentsPre-submission meetings with FDA
• Investigational plans and clinical protocols for FDA review
• 510(k) submissions
• De Novo submissions
• PMA submissions
• CE Technical File submissions
• Health Canada submissions
• FDA 513(g) requests
• FDA Breakthrough Device submissions
• FDA export approvals
• Preparation and guidance for FDA, Notified Body and CA-FDB inspections
• Registration and Listing
• Complaint and incident reporting

The quality of your design documentation is a critical piece of any regulatory submission. Regardless of the device type, Decus can write your design documentation, mentor you as you work on it, or provide oversight review. We can guide you with best practices and project management to generate the high quality documentation needed for regulatory submissions:

• Design History File
• Device Master Record
• Risk Management File
• Usability Engineering File
• Plan and conduct Usability validation studies
• Participate in design reviews

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 or IEC 82304 compliance assessments
• Develop software procedures and templates
• Create procedures and templates for software tool lifecycle management and 21 CFR 11 compliance
• Write verification and validation plans and procedures
• Create test cases for and execute software tool validation
• Review DHF documents for compliance with regulations and standards
• Ensure software risk management compliance with ISO 14791, IEC 62304, and IEC 82304

Decus can help you prepare and execute an entire clinical trial or we can support your team by performing specific tasks. We have designed and conducted multi-site trials and bench and animal 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 Mark Technical Files

Decus has helped many clients establish and/or improve their Quality Systems, enabling them to pass FDA inspections, pass California state inspections, and CE Mark their devices. Decus can help companies to:

• Establish Quality System processes or improve existing procedures to maintain compliance to FDA regulations, the EU Medical Device Regulations, Health Canada’s Medical Devices Regulations, and the related standards:
  • ISO 13485 – Quality System
  • IEC 62304 – Software Medical Device Development
  • IEC 82304-1 – Health software — Part 1: General requirements for product safety
  • ISO 14791 – Risk Management
  • IEC 62366-1 – 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 the 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
• Plan and conduct post-market surveillance activities