Nihar Info Global Interview Questions and Answers

Answers to various technical questions related to quality engineering.

• Six Sigma is a set of techniques and tools for process improvement.

• ISO is an international organization for standardization.

• Least count of vernier caliper is the smallest measurement that can be read.

• Types of measuring instruments include micrometers, calipers, rulers, etc.

• Tolerances can be bilateral or unilateral.

• Fits include clearance fit, interference fit, etc.

• ISO 13485 is a standard for quality manageme...read more

Medical devices can be categorized into various types based on their intended use and complexity.

• Diagnostic devices (e.g. MRI machines, blood glucose monitors)

• Therapeutic devices (e.g. pacemakers, insulin pumps)

• Surgical instruments (e.g. scalpels, forceps)

• Monitoring devices (e.g. ECG machines, pulse oximeters)

• Implantable devices (e.g. artificial joints, stents)

Quality tools are techniques and methodologies used to ensure products or services meet customer requirements and standards.

• Quality tools help identify and solve quality-related issues in a systematic way

• Examples of quality tools include Pareto charts, fishbone diagrams, control charts, and statistical process control

• These tools help in data analysis, problem-solving, decision-making, and continuous improvement

ISO 13485 is an international standard for quality management systems specifically for medical devices.

• ISO 13485 sets out the requirements for a quality management system specific to the medical device industry.

• It is based on the ISO 9001 standard but includes additional requirements for regulatory compliance and risk management.

• Compliance with ISO 13485 is often a regulatory requirement for companies involved in the design, production, and distribution of medical devices.

Medical devices are classified into different grades based on the level of risk associated with their use.

• Medical devices are classified into three main categories: Class I, Class II, and Class III.

• Class I devices are low risk and include items like bandages and tongue depressors.

• Class II devices are moderate risk and include items like powered wheelchairs and infusion pumps.

• Class III devices are high risk and include items like pacemakers and heart valves.

• The classification ...read more