David Walker SPCS

Advancing Performance In Software Development

 

                                                  

6749 S. Westnedge Ave
Portage, MI 49002
ph: 269-352-9000

Software Validation for Medical Devices

Consulting, Validation, Assessments, and Training

Consulting

  • Interpretation of FDA Regulations as they apply to Software
  • Assessment of Software Lifecycle Processes
  • SOP Development
  • Software Safety Risk Management

  Email us for a quote

  Or Call 269.352.9000

 

Software Validation

Have your software validated off site.

  Email us for a quote

  Or Call 269.352.9000

 

 

Resources

Take advantage of the following resources to understand regulatory requirements and industry standards:
  • 21 CFR Part 820 & 11
  • ISO 13485 & 14971
  • IEC 62304 & 60601-1-4
  • IEC 80002 draft -new, ask me abou this
  • IEC 80001 draft -new, ask me about this
  • FDA GPSV

 

Training

  • Developing FDA Compliant Medical Device Software
  • Software Quality Assurance
  • Software Safety Risk Management
  • IEC 62304 Overview

  Email us for a quote

  Or Call 269.352.9000

Audits and Assessments

Understand how your software processes and products align with regulations and standards with an on-site assessment.

  Email us for a quote

  Or Call 269.352.9000

6749 S. Westnedge Ave
Portage, MI 49002
ph: 269-352-9000