Project Governance

 

CERTON Medical understands that both schedule and budget are at risk during the development lifecycle of a project. CERTON Medical can immediately put our expertise to work in order to help your team effectively plan and execute the right tasks, at the right time, and in the right order to ensure all objectives are satisfied to schedule.

 

Our independent validation and verification (V&V) services provide an independent review of your device to support your FDA/CE Mark submission. This is especially vital for companies who may only have a limited number of personnel and are not able to provide the necessary level of independent review.

 

  • Quality system review, then develop and implement a remediation plan, if applicable
  • Complete Quality System development
  • Risk assessment & hazard analysis consulting
  • Process validation – Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ)s
  • Part 11 & HIPAA Compliance review
  • Software quality assurance
  • Minimizing development time and cost
  • Design documentation services

 

IEC 60601 and IEC 62304 Software Systems for Medical Control & Protection

 

CERTON Medical provides services for projects utilizing both IEC 60601 and IEC 62304 Electrical Engineering Standards for Medical Applications. From developing robust software and electronic hardware requirements to verification and validation testing, using CERTON's NextGen Tools and application, CERTON Medical has the expertise to support your project's entire development lifecycle from start to finish at any Safety Integrity Level.