Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Who is the MDSAP Pilot for? 1.47K viewsMedical Device 0 Votes 1 Ans When will the MDSAP go live? 1.71K viewsMedical Device 0 Votes 1 Ans What benefits can manufacturers participating in the MDSAP Pilot enjoy? 1.61K viewsMedical Device 0 Votes 1 Ans Does the MDSAP Pilot add requirements for the manufacturer? 1.50K viewsMedical Device 0 Votes 1 Ans What does the MDSAP certificate represent? 1.50K viewsMedical Device 0 Votes 1 Ans How would manufacturers already holding ISO 13485 certification under the CMDCAS program transition to the MDSAP program? Will a full initial audit be required? 1.68K viewsMedical Device 0 Votes 1 Ans How will audits of medical device manufacturers be conducted under the MDSAP Pilot? 1.48K viewsMedical Device 0 Votes 1 Ans What does the term “off label drug” mean? 1.74K viewsMedical Device 0 Votes 1 Ans Does a person have a right to take legal action if the drug related injury involved a drug that was not prescribed to them by a doctor? 1.65K viewsMedical Device 0 Votes 1 Ans Who can be considered a liable party in the case of injury from a defective drug? 1.74K viewsMedical Device 0 Votes 1 Ans What documentation will I need to provide for a Class I reusable device with regards to cleaning under MDR? 1.62K viewsMedical Device 0 Votes 1 Ans Will I be required to perform testing to ISO 10993 for an equivalent device under MDR? 1.63K viewsMedical Device 0 Votes 1 Ans Will the Periodic Safety Update Report (PSUR) need to be included in the Clinical Evaluation Report (CER) under MDR? 1.77K viewsMedical Device 0 Votes 1 Ans Do the Periodic Safety Update Report (PSUR) and Summary of Safety and Performance requirements (SSP) have to be generated by individual device or can they be generated by device family under MDR? 1.57K viewsMedical Device 0 Votes 1 Ans How does the MDR impact the regulation of device-drug combination products? 1.58K viewsMedical Device 0 Votes 1 Ans Can you summarize any impact of the MDR on devices containing tissues of animal origin and how they are regulated? 1.55K viewsMedical Device 0 Votes 1 Ans When will I need to have implemented the use of UDIs by? Will there be a transition period for existing products? 1.48K viewsMedical Device 0 Votes 1 Ans At what level is the use of UDI no longer applicable, with regards to individually packaged items and items packaged in a single container? 1.54K viewsMedical Device 0 Votes 1 Ans Is the use of UDIs applicable to transport packaging and outer packaging? 1.52K viewsMedical Device 0 Votes 1 Ans Has the EU clarified the use of UDI as it relates to software-only devices? 1.40K viewsMedical Device « Previous 1 2 3 4 5 6 … 13 14 Next » Question and answer is powered by anspress.net
