Quality management for medical device distributors, aligned to ISO 13485.
Prometix includes quality workflows for medical device distributors and service companies, aligned to ISO 13485 and MHRA expectations. Complaints, non-conformances, corrective and preventive actions, internal audits, field safety notices and engineer competence are managed as one connected, evidence-based system, not separate spreadsheets.
What you can do
Everything in one place.
Complaints management
Structured intake, investigation, root cause and resolution, with MHRA / MDR reportability flagged at the point of capture.
Non-conformance and CAPA
A categorised NCR register linked to assets, jobs and engineers, and a CAPA lifecycle from planning to verification.
Internal audits
Plan, conduct and close internal audits against your QMS scope. Findings flow directly into NCRs and CAPAs.
Field safety notices and actions
Connect safety notices to your own equipment, and track holds, follow-up work and corrective sign-off in its history.
Engineer training and competence
See which engineers are authorised for each device model and job type, with training evidence and expiry dates.
Test equipment and calibration
Track every analyser, simulator and calibrator, with calibration due dates and lock-outs for overdue equipment.
FAQ
Questions, answered.
Does ISO 13485 apply to medical device distributors?
ISO 13485 can be used by organisations involved in any stage of a medical device's life-cycle, including storage, distribution, installation and servicing, so many distributors and service companies use it for their quality management system. Certification is voluntary, but customers and tenders often ask for it.
What is the difference between an FSCA and an FSN?
A field safety corrective action (FSCA) is the action a manufacturer takes to reduce the risk from a device already on the market, such as a recall, modification or inspection. A field safety notice (FSN) is the communication that tells customers and users about that action and what to do.
Does using Prometix make us ISO 13485 compliant?
No software makes a company compliant on its own. Prometix gives your quality system connected, evidence-based records aligned to ISO 13485: complaints, NCRs, CAPA, audits, safety actions and competence. Your certification body assesses your quality management system as a whole.