Senior Regulatory Affairs Specialist Interview Questions and Answers

EU MDR process and implications for SaMD

• EU MDR is a regulation that governs medical devices in the European Union

• SaMD refers to software intended for medical purposes

• Under EU MDR, SaMD is classified as a medical device and must comply with the regulation

• Implications include stricter requirements for clinical evidence, post-market surveillance, and data protection

US FDA requirements for 510(k) and PMA involve submission of detailed information and data for review and approval.

• 510(k) submission is required for moderate-risk medical devices to demonstrate substantial equivalence to a legally marketed device.

• PMA submission is required for high-risk medical devices to demonstrate safety and effectiveness through clinical data.

• Both submissions require detailed information on device design, intended use, labeling, manufacturing processes, a...read more

Labeling requirements for products in the regulatory field include providing accurate and clear information to consumers.

• Labels must include product name, ingredients, warnings, directions for use, and contact information for the manufacturer.

• Labels should be in the language of the country where the product is being sold.

• Certain products may require specific labeling such as nutritional information for food products or dosage information for pharmaceuticals.

• Labels must comply...read more