• Analysis of PMS processes and interfaces, GAP evaluation and degree of fulfillment Article 83

• Creation and implementation of a PMS system as an integral part of the quality management system

• Benfit-risk assessment and risk management

• Report on safety and clinical performance in accordance with Article 32 (Summary report of safety and clinical performance)

• Determination of the need for preventive actions, corrective actions or field safety corrective Actions in the field

• Identify ways to improve the usability, performance and safety of the device

• Etc.

• Definition of the clinical endpoints of safety, efficacy and benefit-risk ratio

• Creation and implementation of the PMS plan in accordance with Article 84

• Implementation and collection of market data

• Collecting market feedback from users in hospitals, medical practices and distributors

• Survey of patients, doctors, nurses, users and dealers

• On-site interviews, on the phone or on the internet

• Evaluation of feedback and customer complaints

• Evaluation of information transmitted by users, distributors, dealers and importers

• Assessment of the relevant specialist literature or technical literature, databases and / or registers

• Vigilance System

• Etc.

PMS Report

• Analysis and evaluation of the clinical data

• Preparation of the final report in accordance with Article 85

PSUR

• Preparation and regular update of the periodic safety update report in accordance (PSUR) with Article 86

Analysis

Implementation

Evaluation

WE LEAD 

We lead companies analyzing and implementing their PMS system

We  show you how do develop and implement best PMS strategies to meet regulatory requirements and to beat the market

YOUR BENEFITS

• Thanks to a jointly developed strategy, you can efficiently incorporate latest PMS data into your the anual update of your clinical evaluation and save additional costs and resources.

• Comply with the obligation to detect and report trends in accordance with Arctile 88.

• Independent and objective assessment of the clinical data by external experts, resulting in a higher acceptance by the competent authorities and notified bodies, faster approval process.

• Faster CE approvals for new products or design changes

METHOTOLOGY

• We collect market feedback of users in hospitals, medical practices and distributors

• We perform interview survey of patients, doctors, nurses, users and dealers

• On-site interviews, on the phone or on the internet

• Evaluation of feedback and customer complaints

• Evaluation of information transmitted by users, dealers and importers

• Assessment of the relevant specialist literature or technical literature, databases and / or registers