eSign Protocol Made Easy

Esign protocol

hi this is Rob Packard the medical device Academy this is a brief video explaining what you get when you purchase our design control procedure sys 0:08 this email will come to you automatically after you confirm your desire to subscribe to our automated emails giving you updates to our procedures free the only attachment to this is a design review meeting minutes form there are some the combined file size of the other documents is too large so we are providing hyperlinks to download them from our Dropbox folder so here are the different hyperlinks there's the procedure there's a design transfer checklist a traceability matrix a design and risk management plan that's combined and then there's a bunch of templates for user nior product requirements user needs inputs verification protocol valid verification report and a risk management report template now I'll show you each of those documents so this this procedure has gotten much longer than it was before because we've added quite a bit more detail this is the design control procedure it's now up to 14 pages in this procedure we've listed all the different templates that we are that are included in this Matthew Walker has been very busy adding hyperlinks in color coding he's added in blue color coding for each of the clauses in the standard so it's easy for auditors to find all the regulatory requirements then when you go further down here we explain what things we added throughout the procedure you're gonna see more of these blue references to the different ISO 1345 2016 clauses and we've added a lot more references to the different templates so here's a one of our forums there's a template here's another template and then throughout this we have more blue hyperlinks and more references to templates and then when you go down to the bottom of the procedure and this is all organized by phases so this is stage 4 and then we have stage 5 the final stage for product release and after you get through that it talks about monitoring and measuring what things to monitor in the design process you can modify this to measure the things that you want to measure for your own quality objectives it says who's responsible for the process and what training they need to go through talks about risk management for the process because we use a risk-based approach and all the procedures and it talks about the records and here all the different records that you would put in a design history file organized by phase and this is very much a copy from what's also in the design plan so for each part we've just recently added all the cross references to the different templates to help people keep track of where which documents go where and which sections and then at the end we have our diagram showing the design process this is a combination showing the typical phase Gate approach plus all the risk management activities that would occur and then major milestones in a typical 510 case mission but these could be replaced with European CE Marking requirements as well which would be a little bit shifted out because you can you need to submit clinical data for CE Marking submission is one of the templates so here's a verification report template this is created by Mary Vader she's got in here some software references but this is a very simplified report or template you would add more things in here we have other templates that have more detail if you need them the design review meeting minutes this would be the same review meeting minutes form that you would use for all the design reviews we don't have a separate one for each review we use the same template for each and then you would indicate wouldn't be updated before you go into the next phase this is the design transfer checklist we created this recently to help companies keep track of all the things they need to do during the design transfer process so the person responsible for each of these milestones to make sure they were all completed the target date for completing them in the design transfer and then the data was actually completed so we've got 18 different items here and we have included links to templates as well next item is the design risk management plan template this is a device description that you would put in here that would be the same as what you would use for your designed this device subscription in a 510 K summary just the initial paragraph the general description then we have an overview of the project and then we've broken out each of those boxes as separate Bock tables for each phase and still we have these links for the different documents in here and then we have explanations about what procedures apply and what goes on in between the phases in between each of those tables and see the procedure references we referenced the design procedure here the risk management procedure and the usability procedure and then we say who's responsible for this at the end the next requirement or next template is the risk management report this is in here because we have both the risk management is integrated with the design process we provided this template as well we also provide this as part of our purchase in the risk management procedure and it has the different things that are required at each of the phases and next we have design inputs document I think this is one way to describe it with a lot more detail another way is to use our traceability matrix so we've got a combined design requirements traceability matrix and you could put design inputs here you could also put hazards or if you need more room you could just reference the document where it can be found and what line item it is and then you'd put it in that other document here and indicate what ID it is so design input number one two three four so you'd indicate which one it is and would say it's in template 24 or whatever document number you give it this here is sort of a combination of your input output verification validation io v V as well as the hazard risk management documents that you would need so user needs hazards inputs risk controls severity of harm probability of occurrence of harm or probability of occurrence that's P 1 it's a P 2 over here that you would determine after you gather some clinical data and residual risk that there's a place to put residual risk that you would link in your warnings of precautions in your ifu and then anything that you link for post marco clinical follow-up studies and reports a user needs document here this is a template and once again we have traceability with numbers and you ideally want to have these numbers linked with the inputs and outputs hazards we also have a product requirements document this would also be another user needs type document but it he added even higher level this is more from a business standpoint and last but not least we have the verification protocol template so this says these are the protocol leading into the report that we showed you earlier so those are all the documents that are provided in this it's much longer has a lot more detail we provide a lot more templates and if you have any questions don't hesitate to contact me thank you have a great evening