Medical Device Sustainability and Quality Control

Flashcards for key terms related to medical device sustainability, regulation, and quality control.

Sustainability

Development that meets the needs of the present without compromising the ability of future generations to meet their own needs.

Circular Economy Act (CEAP)

Aims to make sustainable products the norm in the EU.

Ecodesign for Sustainable Products Regulation (ESPR)

Establishes mandatory sustainability requirements for almost all physical products sold in the EU.

Corporate Sustainability Due Diligence Directive (CSDDD)

Requires companies to identify, prevent, and mitigate negative impacts on human rights and the environment in their value chains.

Corporate Sustainability Reporting Directive (CSRD)

Mandates companies to disclose detailed information on their ESG impacts.

ISO 14000 family

Series of international standards for environmental management.

Environmental Management System

A framework for managing an organization's environmental responsibilities.

Life Cycle Assessment (LCA)

A technique to assess environmental impacts associated with all stages of a product's life.

Medical Device Sustainability

Increasing trend towards sustainability in the medical technology sector.

Single-use devices

Devices that are intended to be used once and then discarded.

EU MDR

European Union Medical Device Regulation, governing the market for medical devices.

Energy consumption and greenhouse gas emissions

Regulated aspects that medical devices must benchmark against similar devices.

Raw materials

Crucial element for sustainability in medical device production.

Eco-design

Integrating environmental aspects into product design to reduce environmental footprint.

Supplier management

Monitoring and managing suppliers to observe human rights and environmental regulations.

Risk management system

A system that identifies risks associated with products and mitigates them.

Audit

A systematic examination to assess compliance with criteria.

Vigilance reporting

Mandatory reporting by manufacturers on adverse events related to their medical devices.

Quality Management System (QMS)

A formalized system to document processes and responsibilities for achieving quality objectives.

Regulatory requirements

Laws and regulations governing product safety and efficacy.

Post-market surveillance

Process to monitor the safety of a medical device after it has been released on the market.

Medical device classification

Categorization of medical devices based on risk from Class I (low risk) to Class III (high risk).

CE mark

Conformity marking that indicates compliance with EU safety, health, and environmental protection standards.

Risk analysis in ISO 14971

Systematic process to identify hazards and estimate risk associated with medical devices.

Design Controls

Set of processes that must be followed to ensure a medical device meets user needs and regulatory requirements.

Clinical evaluation

A systematic process to assess the clinical performance and safety of a medical device.

Essential requirements of medical devices

General safety and performance requirements that devices must meet to obtain CE marking.

FDA clearance (510(k))

Premarket submission to demonstrate that a device is as safe and effective as a legally marketed device.

Technical documentation

Documents that manufacturers must prepare to demonstrate the conformity of their devices.

Biocompatibility

The ability of a material to perform with an appropriate host response in a specific situation.

Usability engineering

Ensuring that medical devices are user-friendly and minimize risks associated with user errors.

Ecosystem of medical device regulations

Interconnected regulations that govern the lifecycle of medical devices.

Quality control (QC)

Multi-step process to ensure that every product meets safety and performance standards.

Design transfer

Process of transferring design specifications into manufacturing.

Manufacturing processes

Techniques and methods used in the production of medical devices.

Environmental performance evaluation

Assessing the environmental impacts of a company’s operations.

Zero Pollution Action Plan

Aim for a pollution-free environment by 2050.

Auditable documentation

Records maintained to demonstrate compliance and quality management.

Change control

Process to ensure changes to any part of the device or apparatus are managed and recorded.

Risk-based approach

Taking risks into account when managing product safety and performance.

ISO Standards

International standards used to ensure quality, safety, efficiency, and consistency.

Internal audits

Evaluations of the organization's processes to ensure compliance with internal and external standards.

Harmonized standards

Standards developed to facilitate compliance with EU legislation.

Post-market clinical follow-up (PMCF)

Planned data gathering post-market to monitor the long-term safety of a device.

Smart regulatory practices

Use of advanced methodologies to streamline product approvals and marketing.

EU Declaration of Conformity

A document by which the manufacturer confirms that a medical device meets all applicable EU regulations.

Eudamed

European Database on Medical Devices, facilitating data collection on medical devices.

Technical file

Documentation that includes all necessary evidence demonstrating the compliance of the device with regulatory requirements.

Risk management plan

Document detailing how risks will be identified, analyzed, and mitigated.

Environmental impact assessment

Evaluation of the potential environmental impacts of a proposed project or product.

Stakeholder engagement

Involving all relevant parties in the decision-making processes related to medical devices.

ISO TR 24971:2020

Guidance document for the application of ISO 14971 for medical devices.

Clinical investigation report

Documentation summarizing the results of the clinical investigation of a device.

End of life management

Strategies for disposing, recycling, or reprocessing medical devices at the end of their lifecycle.

Supplier evaluation

Process for assessing and selecting suppliers based on their ability to meet a company's requirements.

Ethics in medical device development

Moral principles guiding the conduct and development of medical devices.

User training

Instruction provided to users on the proper use and handling of medical devices.

Market surveillance

Oversight activities carried out to ensure that medical devices on the market continue to meet safety and performance requirements.

Fast-track medical device approval procedures

Accelerated processes designed to hasten the entry of essential medical technologies to the market.

Design and development,

Set of interrelated processes involved in creating and improving medical devices.

Regulated medical device software

Software that meets standards and regulatory requirements for safety and effectiveness.

Human factors engineering

Disciplinary approach focusing on user-centered design of devices to enhance usability.

Post-market risk assessment

Ongoing evaluation of the risk associated with a medical device after it has been released to determine any necessary corrective actions.

Biological evaluation

Assessment of medical devices to identify potential biological effects on the body.

Regulatory framework for medical devices

Laws, regulations, and guidelines governing medical device marketing and surveillance.

Quality compliance

Ensuring that products meet specified standards and regulations.

Adverse event reporting

Obligation to report incidents that resulted in adverse outcomes following device use.

Stakeholder involvement in device design

Engagement of different groups in the design process to address user needs and safety.

Medical device lifecycle management

Strategies that manage the entire lifecycle of a medical device from conception to disposal.

Informed consent in clinical trials

Process to obtain agreement from a patient or volunteer before participation in a clinical trial.

Device registration process

Steps a manufacturer must follow to legally market a medical device.

Regulatory compliance audits

Regular checks conducted to ensure conformity with relevant regulations.

Risk control measures,

Actions taken to mitigate identified risks during the lifecycle of a medical device.

Clinical trials approval process

Phased evaluation that devices must go through to demonstrate their safety and efficacy before market release.

Public health impact of medical devices

Effect that medical devices have on the health outcomes of populations.

Interdisciplinary teams in device development

Groups that combine expertise from various disciplines to enhance device innovation.

Cost-effectiveness in medical device deployment

Analysis of the cost relative to the benefits and cost-savings provided by a medical device.

Risk management documentation requirements

Regulations regarding the recording and reporting of risk assessments and control measures.

Financial implications of regulation compliance

The costs associated with adhering to medical device regulations.

Cross-functional collaboration

Cooperation between different departments to ensure success in medical product development.

End-user input in design validation

Including feedback from actual users during product design to enhance usability.

Device safety evaluation

Assessment procedures to determine the safety profile of a medical device.