Post-Market Surveillance System For Medical Device Manufacturer

PMS System

According to Article 83 of MDR 2017/745, medical device manufacturer have to implement a PMS system (post market surveillance system). Article 83 requires that the PMS system has to be an integral part of the manufacturer's quality management system.

PMS Data Collection and Monitoring

Starting with the PMS data collection and analysis up to the data evaluation, our service includes the full range of post market surveillance activities and monitoring for medical device manufacturer.

 

We provide following tailored services to your need

PMS System

PMS Plan

PMS Report

  • 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
 

Who we are

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

 

Our Clients & Expertise

  • Drug delivery systems, drug pens, insulin pumps, infusion systems

  • Drug coated coronary stents and guide wires

  • Balloon catheters

  • Bone and dental implants, hip implants

  • HF generator, endoscopes, robotic systems and surgical instruments

  • Biopsy needles, snares, catheter systems

  • Dialysis, LDL apheresis

  • Invitro diagnostic, blood glucoses, bio-markers and small peptides

  • ECG and intensive care monitoring, ultrasonic devices

Partners

 

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Contact

Tel.: +41 79 858 482 5

Bellingswood Group GmbH

Thurgauerstrasse 117

8152 Glattpark - Zürich

Switzerland

Further Information

We are happy to provide you further information and to answer your questions.
 

Bellingswood

LINKS
Contact

Bellingswood Group GmbH

Thurgauerstrasse 117

8152 Glattpark - Zürich

Switzerland

​​​

Tel: +41 79 85 84 825

​​

info@bellingswood.com

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Bellingswood

LINKS
Contact

Bellingswood Group GmbH

Thurgauerstrasse 117

8152 Glattpark - Zürich

Switzerland

​​​

Tel: +41 79 85 84 825

​​

info@bellingswood.com

Social Networks
  • White LinkedIn Icon
  • White Facebook Icon
  • White Twitter Icon
  • White Google+ Icon