Regulatory Engineer Interview Questions and Answers

Outsource testing to accredited laboratories, gather documentation and evidence of compliance, and work closely with notified bodies.

• Outsource testing to accredited laboratories to meet MDR requirements.

• Gather documentation and evidence of compliance from suppliers and manufacturers.

• Work closely with notified bodies to ensure all necessary steps are taken for MDR submission.

Design verification ensures the product is designed correctly, while design validation ensures the correct product is designed.

• Design verification confirms that the design output meets the design input requirements.

• Design validation confirms that the product meets user needs and intended use.

• Verification is done before validation in the design process.

• Verification can include activities like reviews, inspections, and testing.

• Validation typically involves testing the actual pr...read more

Design input is what the product should do, design output is what the product actually does.

• Design input is the requirements and specifications provided by the customer or user.

• Design output is the final product or system that meets the design input requirements.

• Design input is the 'what', design output is the 'how'.

• Examples: Design input - product must be waterproof. Design output - product passed waterproof testing.

• Design input is the starting point, design output is the en...read more

Labeling changes from MDD to MDR involve stricter requirements and more detailed information.

• Under MDR, labeling must include Unique Device Identification (UDI) for better traceability.

• MDR requires more detailed information on the device, its intended use, and instructions for use.

• Labeling changes may also involve updating symbols, warnings, and precautions to align with MDR requirements.