Demo video transcript: an rmForge working session

0:00This is an rmForge working session. I'm Mike Reo, the founder of rmForge. Let's get started. Okay, in this demo analysis, we're going to start off with six simple steps.

0:13There's going to be a hazard identification questionnaire. We're going to start filling that out right now. So, the customer organization is X Vascular.

0:22Engineer name is RM Engineer. It is a single component, and the device name was called XLK. Okay, now we need to fill in the intended use.

0:34Intended clinical use, we're going to pull that from a canned IFU that was publicly available. Is it life-supporting? No, and the three-letter product code is MAF.

0:45rmForge has over 6,000 FDA product codes in it. And from here, it's not absorbable. It's an implant, direct blood path, and so on and so on.

0:55We make these selections, surgeon implanted, no network transmission or alarm system, and continue. From here, we're going to be doing a hazard analysis today, nothing else, so we can skip past this.

1:07And we want to include, none of the above for user requirements because this is a preliminary analysis. Likewise, same for PRs or product requirements.

1:15There's none available. And this simulation, and then design input output matrix, none available. We are going to upload a synthetic IFU that we ginned, so we can click and upload that.

1:26Okay, we have uploaded a synthetic IFU, and now we can come down to optional details for this record. rmForge allows the customization for user requirement IDs, product requirement IDs, and design input-out matrices.

1:39We're going to put in the starters for this because it's going to make suggestions. So just say, some basic syntax, and this is, can be customized according to the customer.

1:49And we'll just give a customer reference of XLK. And then our risk control measure implementation prefixes will be components, sub-assemblies, and IFU for this demo.

1:59And then our verifications for RCM are going to be test protocols because rmForge does make recommendations across all three horizons of risk control measures.

2:07So we'd like to add in does the device have any unique features? And we're going to paste those in. Any standards that are of interest?

2:13I'll grab those from a spec sheet. And drop those in. A couple of standards. Anything else? We'll just say that this is a first generation.

2:23I'm going to say no history, and then we just knock out the disclaimers, put the name. And title. And sign and submit.

2:35And rmForge will begin forging a hazard analysis. It goes through each step and shows you how it's progressing. Once it's done, it will email you a completed hazard analysis.

2:46We'll cover that in just a moment. Okay, our analysis is complete. It took about 11 minutes to do a bare metal stent, and now we can download the result.

2:55here is the downloaded result. So, we have all of the standardized columns, risk ID, general hazard, use classification according to IEC 62366, foreseeable events, hazardous situation, harm, risk level, skipping essential performance because this is not medical electrical equipment, and then risk control

3:15measures, options, design, protection, information for safety, RCM requirements, implementation, and verification. And rmForge, as you can see, has generated suggested PRs, suggested components, and subsystems.

3:31Assemblies, IFU recommendations, as well as suggested test protocols for future verification work. And, naturally, there is a residual section, however, is not being completed because the RCMs are not complete, but they will be in subsequent revisions.

3:45And the last column is new risks created from our risk control measures, which there are none, of course, because we've not completed our risk control measures.

3:54rmForge allows revisions of this according to team input with red lines, and it can handle updating for an additional revision.

4:02Each of the tabs, Cover Page, Hazard Analysis, Risk Region, Scales, Column Descriptions, Hazard Questionnaire, Disclaimer, and PR Register are included in the workbook.

4:16That concludes the demo. rmForge produces a hazard analysis in less than a day, usually in minutes, with no need to learn new software.

4:23Thank you for watching.