Top Medical Devices Questions & Answers | Clinoxy

Medical Devices Course | Medical Device Training | Top Medical Devices Institute in Hyderabad – Clinoxy

A medical device is any instrument, apparatus, or machine used for diagnosis, prevention, monitoring, or treatment of diseases in humans.

Drugs achieve their effects through chemical action, whereas medical devices work through physical or mechanical means.

Examples include pacemakers, insulin pumps, syringes, stents, thermometers, and X-ray machines.

Devices are categorized as Class I, II, and III based on their risk level.

• Class I: Low risk (e.g., bandages, stethoscopes)
• Class II: Moderate risk (e.g., infusion pumps, contact lenses)
• Class III: High risk (e.g., pacemakers, heart valves)

RA ensures that devices comply with government regulations and quality standards before they enter the market.

Key standards include ISO 13485 (Quality Management) and ISO 14971 (Risk Management).

It specifies quality management system requirements for organizations involved in medical device design, production, and servicing.

It provides a systematic process for identifying, analyzing, and controlling risks associated with medical devices.

CE marking indicates that a medical device complies with the European Union’s safety, health, and environmental protection requirements.

1. Concept & feasibility
2. Design & prototyping
3. Pre-clinical testing
4. Clinical evaluation
5. Regulatory approval
6. Manufacturing & post-market monitoring

It ensures that medical device design meets user needs, intended use, and regulatory requirements.

A Technical File contains all documentation proving that a device meets regulatory requirements for safety and performance.

A premarket submission to the U.S. FDA showing that a new device is substantially equivalent to a legally marketed device.

PMA is the FDA process of scientific and regulatory review for Class III devices to ensure safety and effectiveness.

It’s the continuous monitoring of a device’s performance after it reaches the market.

It’s the continuous monitoring of a device’s performance after it reaches the market.

It’s the continuous monitoring of a device’s performance after it reaches the market.

It involves identifying potential hazards, estimating risks, and implementing measures to reduce them.

They evaluate how easily and safely users can operate a medical device.

MDR (Regulation EU 2017/745) governs the manufacturing and distribution of medical devices in Europe.

MDR (Regulation EU 2017/745) governs the manufacturing and distribution of medical devices in Europe.

Unique Device Identification — a system used to mark and identify medical devices through their lifecycle.

The Central Drugs Standard Control Organization is India’s national regulatory authority for drugs and medical devices.

Independent organizations authorized to assess the conformity of devices before market approval in Europe.

Products that combine drugs, devices, or biologics (e.g., drug-coated stents).

It ensures that sterilization methods effectively eliminate all viable microorganisms.

GMP ensures that devices are consistently produced and controlled according to quality standards.

Device Master Record (DMR), Device History Record (DHR), and Design History File (DHF).

Knowledge of quality systems, regulatory standards, documentation, problem-solving, and teamwork.