[sciclaw]

There are a lot of ongoing costs as well. Medical insurance is expensive, and there's a lot of process that is ongoing. A lot of effort goes into security, both monitoring and pushing updates. Medical device companies must also undergo regular audits of our quality systems, look up QMS/eQMS, where FDA reps will spend about 1 week a year reviewing everything we've done over the last year. Generating all the documents for those audits takes a lot of time (aka cost). That's not complete list, but this is in addition to regular SaSS costs.