Quality Assurance

PULSION's main product developments are in the fields of anaesthesia, surgical and internal intensive care medicine, cardiology, as well as ophthalmology and tumor therapy. PULSION Medical Systems is superior in the development of practice-oriented monitoring systems and disposables that are used for diagnosis and treatment of the patient.

 

We assure with our products the highest standard of quality ...
... to guarantee our customers the highest possible success in therapy.

 

PULSION Medical Systems AG sets the highest quality assurance standards to continuously fulfil the requirements according to EU regulations of the MDD, DIN EN ISO 13485:2012 + AC:2012, as well as the requirements of the FDA in the US, US FDA 21 CFR Part 820.

To achieve these targets ...

  • ... PULSION has a complete Quality Assurance System according to the norm DIN EN ISO 13485:2012 + AC:2012
  • ... development, production and management processes are continuously controlled by our QM staff.
  • ... all employees are trained in quality assurance and are included in the implementation, maintenance and improvement of the system.


DEKRA Certificate DIN EN ISO 13485:2012

DEKRA Certificate acc. Annex II