Risk management system

Risk management system

RISK MANAGEMENT SYSTEM

Risk management is a continuous iterative process throughout the entire lifecycle of a medical device. Its purpose is to account for and reduce risks associated with the use of the device. Risk management system must be documented and requires regular systematic updating. Risk management plan is the pivotal document of the Risk Management System.

European Union, USA and Mexico require that all manufacturers of medical devices develop and maintain Risk Management Systems regardless of risk-classes of their devices. In Mercosur countries (Argentina; Brazil; Paraguay; Uruguay) and associated states (Suriname, Guyana, Colombia, Ecuador, Peru, Chile and Bolivia) Risk Management System is a requirement for high-risk products.

Risk Management System requirements for the European Union are laid down in Annex I of Regulation EC 2017/745 (2017/746 - for in vitro medical devices). In the USA corresponding provisions are set out in the Code of Federal Regulations - 21 CFR 820.30 and in the FDA guidance Q9.

A number of methods and instruments are used for risk analysis and management. Some of them are ISO 14971, FMEA, HAZOP, FTA etc. Different medical devices require different risk management approaches.

Risk Management System is closely related to the Post-Market Surveillance System and Clinical Follow-Up and is an integral part of the Quality Management System. It should be incorporated within research and development processes and reflect the engineering aspects of a product and risks associated with them.

Medical device manufacturers who want to sell their devices on global markets need to create a Risk Management System and manage risks associated with the use of each of their products. MDRS assists medical device companies with risk management. We will develop and implement a Risk Management System that is compliant with regulatory requirements of your target markets.

RISK MANAGEMENT SYSTEM

Risk management is a continuous iterative process throughout the entire lifecycle of a medical device. Its purpose is to account for and reduce risks associated with the use of the device. Risk management system must be documented and requires regular systematic updating. Risk management plan is the pivotal document of the Risk Management System.

European Union, USA and Mexico require that all manufacturers of medical devices develop and maintain Risk Management Systems regardless of risk-classes of their devices. In Mercosur countries (Argentina; Brazil; Paraguay; Uruguay) and associated states (Suriname, Guyana, Colombia, Ecuador, Peru, Chile and Bolivia) Risk Management System is a requirement for high-risk products.

Risk Management System requirements for the European Union are laid down in Annex I of Regulation EC 2017/745 (2017/746 - for in vitro medical devices). In the USA corresponding provisions are set out in the Code of Federal Regulations - 21 CFR 820.30 and in the FDA guidance Q9.

A number of methods and instruments are used for risk analysis and management. Some of them are ISO 14971, FMEA, HAZOP, FTA etc. Different medical devices require different risk management approaches.

Risk Management System is closely related to the Post-Market Surveillance System and Clinical Follow-Up and is an integral part of the Quality Management System. It should be incorporated within research and development processes and reflect the engineering aspects of a product and risks associated with them.

Medical device manufacturers who want to sell their devices on global markets need to create a Risk Management System and manage risks associated with the use of each of their products. MDRS assists medical device companies with risk management. We will develop and implement a Risk Management System that is compliant with regulatory requirements of your target markets.

We will implement a Risk Management System at your company that complies with ISO 14971 and regulatory requirements of your target markets

ISO 14971 is a standard for the application of risk management to medical devices recognized worldwide

  • ISO 14971 is an internationally recognized standard used by medical device companies to create and implement the Risk Management System conforming to the requirements of most regulatory agencies worldwide. The standard is recognized by the European Notified Bodies, FDA, Health Canada and regulatory authorities of Latin American countries.
  • ISO 14971 is harmonized with the European Regulations EC 2017/745 (medical devices) and 2017/746 (in vitro diagnostic devices), ISO 13485 and 21 CFR Part 820.
  • EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 and the latest version, 14971:2019, remain the standard recommended for medical device risk management purposes.
  • ISO 14971 is an internationally recognized standard used by medical device companies to create and implement the Risk Management System conforming to the requirements of most regulatory agencies worldwide. The standard is recognized by the European Notified Bodies, FDA, Health Canada and regulatory authorities of Latin American countries.
  • ISO 14971 is harmonized with the European Regulations EC 2017/745 (medical devices) and 2017/746 (in vitro diagnostic devices), ISO 13485 and 21 CFR Part 820.
  • EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 and the latest version, 14971:2019, remain the standard recommended for medical device risk management purposes.

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Send us an email at: info@mdrc-consulting.com

Or use the contact form      

ISO 14971 is associated with other risk-related standads

IEC 60601-1

Requirements for basic safety and essential performance of medical electrical equipment

21CFR 820

Quality management systems (USA)

IEC 62366

Application of usability engineering to medical devices

IEC 62304

Medical device software

ISO 13485

Quality management systems (EU/international)

ISO 14155

Clinical investigation of medical devices for human subjects

ISO 31000

Risk management (interdisciplinary)

ISO 80001

Application of risk management for IT-networks incorporating medical devices

ISO 14971 is associated with other risk-related standads:

IEC 60601-1

Requirements for basic safety and essential performance of medical electrical equipment

21CFR 820

Quality management systems (USA)

IEC 62366

Application of usability engineering to medical devices

IEC 62304

Medical device software

ISO 13485

Quality management systems (EU/international)

ISO 14155

Clinical investigation of medical devices for human subjects

ISO 31000

Risk management (interdisciplinary)

ISO 80001

Application of risk management for IT-networks incorporating medical devices

12+

YEARS’ EXPERIENCE

200+

COMPLETED PROJECTS

100+

SUBMISSIONS

50+

NEW PRODUCTS

How MDRC assists medical device companies whith implementing Risk Management Systems:

  • The allocation of responsibilities related to risk management
  • Risk management team formation
  • ISO 14971 training
  • GAP-analysis for all the products
  • Using existing safety data on every product
  • Obtaining the missing clinical data
  • Elaboration and implementation of Risk Management System
  • Preparing Risk Management Files

How MDRC assists medical device companies whith implementing Risk Management Systems:

  • The allocation of responsibilities related to risk management
  • Risk management team formation
  • ISO 14971 training
  • GAP-analysis for all the products
  • Using existing safety data on every product
  • Obtaining the missing clinical data
  • Elaboration and implementation of Risk Management System
  • Preparing Risk Management Files

Post-market surveillance system

Post-market surveillance system

Post-market surveillance is the practice of monitoring the safety of a medical device after it has been released on the market. It includes all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.

Post-market surveillance is the practice of monitoring the safety of a medical device after it has been released on the market. It includes all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.

POST-MARKET SURVEILLANCE SYSTEM

Post-market Surveillance System is an integral part of the medical device manufacturer's Quality Management System. How the system is organized and how it works depends on risk-based classification of products the company manufactures and sells. Post-market Surveillance System is a binding regulatory requirement in the EU, USA and some other countries. In Latin American countries the regulatory authorities expect that it is Authorized Representatives who have Post-market Surveillance Systems and not importers.

The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.

In the European Union post-market surveillance is regulated by Articles 83-86 of Chapter VII and Annex III of Regulation EC 2017/745 or by Section 1 of Chapter VII and Annex III of Regulation EC 2017/746. In the USA post-market surveillance provisions are laid down in section 21 CFR Part 822 of the Code of Federal Regulations.

The basic documents of any Post-Market Surveillance System are Post-Market Surveillance Plan and Post-Market Surveillance Reports. In the European Union and USA manufacturers of high-risk medical devices (e.g. classes IIb and III in the EU or class III in the USA) must provide Periodic Safety Update Reports (PSUR) to the regulators. In some countries (for instance, in the USA) regulators may request intermediate post-market surveillance data and carry out surprise inspections of manufacturers' Post-Market Surveillance Systems.

POST-MARKET SURVEILLANCE SYSTEM

Post-market Surveillance System is an integral part of the medical device manufacturer's Quality Management System. How the system is organized and how it works depends on risk-based classification of products the company manufactures and sells. Post-market Surveillance System is a binding regulatory requirement in the EU, USA and some other countries. In Latin American countries the regulatory authorities expect that it is Authorized Representatives who have Post-market Surveillance Systems and not importers.

The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.

In the European Union post-market surveillance is regulated by Articles 83-86 of Chapter VII and Annex III of Regulation EC 2017/745 or by Section 1 of Chapter VII and Annex III of Regulation EC 2017/746. In the USA post-market surveillance provisions are laid down in section 21 CFR Part 822 of the Code of Federal Regulations.

The basic documents of any Post-Market Surveillance System are Post-Market Surveillance Plan and Post-Market Surveillance Reports. In the European Union and USA manufacturers of high-risk medical devices (e.g. classes IIb and III in the EU or class III in the USA) must provide Periodic Safety Update Reports (PSUR) to the regulators. In some countries (for instance, in the USA) regulators may request intermediate post-market surveillance data and carry out surprise inspections of manufacturers' Post-Market Surveillance Systems.

If you are interested in placing your medical devices on global markets your company should implement the Post-Market Surveillance System.

If you are interested in placing your medical devices on global markets your company should implement the Post-Market Surveillance System.

We are pleased to assist you in creating your Post-Market Surveillance System that complies with regulatory requirements of your target markets.

We are pleased to assist you in creating your Post-Market Surveillance System that complies with regulatory requirements of your target markets.

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