More helpful advice from Etienne. Give him a follow!
What is a Device Master Record (DMR)? It's the recipe + ingredients list + knowledge of how it should all taste when it's done. These are the 3 things I think of: 1. Assembly drawings (including Bill of Materials) 2. Assembly instructions (including packaging and labeling) 3. Inspection instructions Here's how the actual FDA regulation is worded: 21 CFR Part 820.181: Each manufacturer shall maintain device master records (DMR's). And DMRs shall include (or refer to the location of) the following: 𝟭. 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 Which includes: ✅ Assembly Drawings ✅ Component specs ✅ Software specs ✅ Composition ✅ Formulation 𝟮. 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 Which includes: ✅ Production methods ✅ Production procedures ✅ Equipment specifications ✅ Production environment specifications 𝟯. 𝗜𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲𝘀 Which include: ✅ Procedures showing the acceptance criteria ✅ Inspection equipment needed 𝟰. 𝗣𝗮𝗰𝗸𝗮𝗴𝗶𝗻𝗴 𝗮𝗻𝗱 𝗹𝗮𝗯𝗲𝗹𝗶𝗻𝗴 𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 ✅ Methods and processes used; and 𝟱. 𝗢𝘁𝗵𝗲𝗿 𝗽𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲𝘀 Which includes: ✅ Servicing ✅ Installation ✅ Maintenance You got this. 👊 --- 👍 If this was helpful, be sure to 𝗦𝗵𝗮𝗿𝗲 with others! 🙌 #MedicalDevices #greenlightGuru #HealthCare
