Support and Regulatory Considerations

When developing a medical device, documentation to record important decisions, specifications and procedures is important.  Each industry has its own regulatory concerns which must be met for successful product launch; the medical device industry’s are quite stringent.  We have a deep knowledge of what it takes to set up a successful documentation system for a medical device and how to design for compliance with both industry-standard and medical-specific regulations.


A strong documentation system is the foundation for a successful medical product.  We can help you identify the extent of documentation necessary, then create and maintain your documentation system to the required medical device standards.

  • Project development plan
  • Block diagrams
  • Timeline
  • Budget estimate
  • Requirements & specifications
  • Engineering design collateral, such as PCB layout files, schematics, mechanical models, simulations, etc
  • Bill of Materials (BOM)
  • Implementing a part numbering system
  • Validation plans and results
  • Standard operating procedures (SOPs)
  • Change orders
  • Corrective action requests

Compliance and Safety

Medical devices are subject to numerous standards for compliance and safety.  We can help you understand what standards you need to meet and how to comply with them properly.

  • Electromagnetic compliance (EMC)
  • Safety, such as IEC 60601-1 for medical devices
  • Development process documentation, such as ISO 14971 (hardware) and IEC 62304 (software)
  • Preparing for FDA 510k filing
  • Specialized standards for specific medical device classes