A quality management system is a set of policies, processes, procedures, and measures used for a purpose.

  1. What is that purpose ?: that an organization can achieve its objectives.
  2. What are the main objectives?: satisfy customer requirements and meet the regulatory requirements

“A management system is neither paperwork nor just to complete a series of activities”.”


QUALIPHARMA MEDICAL DEVICES puts at the service of our clients, experts to support them in the fulfillment of the requirements established in the regulations of medical devices:

  • Advice and implementation of Quality Systems according to EN ISO 13485.
  • Internal review audits.
  • Support during inspections of notified bodies or competent health authorities.
  • Maintenance of its Quality System.
  • TR 80002-2: 2017: We validate the software used for the quality management system and thus be able to comply with the new requirement established in the Standard EN ISO 13485: 2016.