Medical Device Startup SOP Checklist

Growing medical device companies often know they need SOPs, but deciding which procedures should come first can be difficult. The Medical Device Startup SOP Checklist provides a practical starting point for identifying the procedures, records, responsibilities, and controls that may be needed as your quality system develops.

Use the checklist to review areas such as:

• document and record control
  
• training and competency
  
• complaint handling and investigation
  
• CAPA and nonconformance
  
• supplier controls
  
• risk management
  
• software and system controls
  
• management review and quality oversight
  

The goal is not to create every procedure at once. It is to understand which processes matter for your organization now, which can be developed later, and where gaps could create unnecessary regulatory or operational risk.

Groundwork Quality Systems is built around a simple principle: Quality owns the framework. The business owns the work. A useful quality system should support how the company actually operates while providing the controls expected in an ISO 13485:2016 and FDA QMSR-aligned environment. When you are ready to put those systems into practice, explore the Medical Device Document Control Starter Kit and the Medical Device Complaint Management & Investigation Starter Kit for editable procedures, worksheets, guides, and implementation tools.