Podcast
Questions and Answers
What is the requirement for language in the user manual for devices sold in Canada and the USA?
What is the requirement for language in the user manual for devices sold in Canada and the USA?
- It must be written in both English and French
- It must be written in French only
- It must be written in the official language of the purchaser's jurisdiction
- It must be written in English only (correct)
Under what circumstance will Swift Medical translate the materials to French?
Under what circumstance will Swift Medical translate the materials to French?
- If the materials are not available in French
- If requested by a Canadian customer (correct)
- If requested by a US customer
- If the manufacturer is based in Quebec
What is the manufacturer's responsibility regarding directions for use in other jurisdictions?
What is the manufacturer's responsibility regarding directions for use in other jurisdictions?
- To include them in the user manual
- To make them available upon request of the purchaser (correct)
- To provide them in both English and French
- To ensure they are written in the official language of the purchaser's jurisdiction
What is the purpose of validating packaging integrity according to international shipping standards?
What is the purpose of validating packaging integrity according to international shipping standards?
What is the purpose of recording control numbers in the production report form?
What is the purpose of recording control numbers in the production report form?
What is included in the validation of electronic labelling?
What is included in the validation of electronic labelling?
What is the purpose of the designated Product Storage area at Swift Medical?
What is the purpose of the designated Product Storage area at Swift Medical?
What is the purpose of the labeling procedure outlined in the text?
What is the purpose of the labeling procedure outlined in the text?
What products does the labeling procedure apply to?
What products does the labeling procedure apply to?
What is the main goal of providing warnings and cautions in the labeling procedure?
What is the main goal of providing warnings and cautions in the labeling procedure?
What is the scope of the labeling procedure?
What is the scope of the labeling procedure?
What information must be included on the label of a medical device according to the text?
What information must be included on the label of a medical device according to the text?
What additional information must be included on the label of an investigational testing drug in the United States according to the text?
What additional information must be included on the label of an investigational testing drug in the United States according to the text?
What is the purpose of including the batch code on a medical device label according to the text?
What is the purpose of including the batch code on a medical device label according to the text?
What type of products may provide instructions for use in electronic form only according to the text?
What type of products may provide instructions for use in electronic form only according to the text?
What is the purpose of stating the performance specifications of an investigational testing drug on the label according to the text?
What is the purpose of stating the performance specifications of an investigational testing drug on the label according to the text?