Latest Risk Management guideline (ISO 14971:2019) & Environmental aspects of Medical Device

  • Sunaina Mishra Drug Regulatory Affairs
  • Vikesh Kumar Shukla

Abstract

The use of medical device in patient is a critical step and requires an appropriate management system for its best practice and use throughout its complete lifecycle. Various countries around the globe have procedures and regulations in place for the safe production and use of their medical device. CDSCO, GOI (Government of India) under directorate general of health services in ministry of health and family welfare are the governing body in India which is responsible for the safe & effective use of medical device on patients under Medical Device Regulations, 2017. Recently, the third version of ISO 14971:2019 series has been notified and several aspects of this regulation include the best objectives to be achieved by the manufacturer by being compliant with the risk management plan set forth in the international standard on risk management system. ISO 14971 for medical device ensure companies produce a product which is safe and effective for use and for patients who unknowingly tend to accept the risk related to medical device which the experts design and manufacture. Risk management standard help a manufacturer build a risk management plan and carry out activities in compliance with the international guideline so as to minimize the risk possibility, occurrence and any hazard associated with it. This article focuses on the importance of ISO 14971 and structure the aim and standard. It also throws light towards the environmental aspects as an element of the management process relating to the threat posed to the surroundings by their use, as well as with various other steps taken by the companies to make the public aware of the product they use and unknowingly support the risk posed by the material that the product is composed of. Bio medical waste management is an initiative undertaken by India for the safe disposal and treatment of bio medical waste generated around us by various primary and secondary sources. This article gives a brief overview of guidance on risk assessment, management and control plans to be implicated by the company and steps taken to tackle and reduce harm to the environment posed by medical devices.

Keywords: Medical device, Risk Management System, Risk Management Plan, Biomedical Waste Management, Hazard, Safety & Efficacy, BRA, Sustainability, Environment

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How to Cite
Mishra, S., and V. K. Shukla. “Latest Risk Management Guideline (ISO 14971:2019) & Environmental Aspects of Medical Device”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 2, June 2020, pp. 15-24, doi:10.22270/ijdra.v8i2.387.

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