Software Compliance

IEC 62304:2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

All the services you need,
all in one place.

Many medical devices contain software components or parts which monitor or control the system, such as:
  • firmware or other software-based control
  • stand-alone software applications
  • device-related software
  • dedicated hardware/software for medical devices
  • accessories to medical devices
Applicable documents for software compliance:
  • software development plan
  • software description
  • hazard analysis & risk assessment
  • software requirements
  • architecture design
  • software design
  • verification & validation
  • traceability
  • development environment
  • management of issues
REGULATION (EU) 2017/745 Rule 11:
"Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: 
— death or an irreversible deterioration of a person's state of health, in which case it is in class III; or 
— a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb. 

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software is classified as class I."
Book Service

Interested in our services? We’re here to help!

We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help. 
Book an appointment