Medizintechnik Medical technology

Risk management and compliance of software and electronics in medical technology

At AVQ, you can expect individualized support and tailor-made advice for your requirements in the field of approval of medical devices (DIN EN 60601), risk management file (DIN EN 14791), medical software (IEC 62304).We provide support for safety-related software development of software classes A, B, C and for customer approval.Experienced and professional AVQ Safety Consultants "treat the side effects of medicine 4.0" for distributors and system integrators of medical technology systems and have several years of safety experience with systems, hardware, software and processes.

 

Additional topics

Other AVQ topics in medical technology besides risk management according to ISO 14971 and safety in general are

  •      ISO13485 (quality management)
  •      IEC62366 (usability)
  •      IEC60601-1 (devices, focus on hardware)
  •      IEC62304 (software)
  •      ISO80001 (IT security)

Services

  • Risk analysis and management
  • Safety consulting SW development
  • Electric / Electronic E/E topics of the medical device directive