Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What are the 4 Document Control Gaps That Can Cause Big Problems and How to Avoid Them? 966 viewsFDA 0 Votes 1 Ans What is “Network Drives and Email” document control gaps and what you can do to fix them? 1.15K viewsFDA 0 Votes 1 Ans What is “Lack of Integration” document control gaps and what you can do to fix them? 1.17K viewsFDA 0 Votes 1 Ans What is “Audit Problems” document control gaps and what you can do to fix them? 1.01K viewsFDA 0 Votes 1 Ans If a change to the UDI Device Identifier (UDI-DI) requires an update to the EC certificate, how long will this take? 1.62K viewsMedical Device 0 Votes 1 Ans What is the MDSAP? 1.52K viewsMedical Device 0 Votes 1 Ans What is the MDSAP Pilot Program? 1.51K viewsMedical Device 0 Votes 1 Ans Who is the MDSAP Pilot for? 1.42K viewsMedical Device 0 Votes 1 Ans When will the MDSAP go live? 1.66K viewsMedical Device 0 Votes 1 Ans What benefits can manufacturers participating in the MDSAP Pilot enjoy? 1.57K viewsMedical Device 0 Votes 1 Ans Does the MDSAP Pilot add requirements for the manufacturer? 1.47K viewsMedical Device 0 Votes 1 Ans What does the MDSAP certificate represent? 1.46K 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? 1.65K viewsMedical Device 0 Votes 1 Ans How will audits of medical device manufacturers be conducted under the MDSAP Pilot? 1.44K viewsMedical Device 0 Votes 1 Ans What does the term “off label drug” mean? 1.70K 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? 1.62K viewsMedical Device 0 Votes 1 Ans Who can be considered a liable party in the case of injury from a defective drug? 1.69K 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? 1.58K viewsMedical Device 0 Votes 1 Ans Will I be required to perform testing to ISO 10993 for an equivalent device under MDR? 1.57K 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? 1.73K viewsMedical Device « Previous 1 2 … 186 187 188 189 190 … 283 284 Next » Question and answer is powered by anspress.net