Start-up medical device companies often focus on regulatory filings and device classification, but their Quality Management Systems (QMS) frequently fail to reflect actual organizational processes. Many QMS are either overly complex or incomplete. With the FDA aligning 21 CFR 820 with ISO 13485, companies must ensure their systems meet both regulatory and operational needs. A practical starting point is developing a clear Quality Manual (QM) to establish an effective and compliant QMS framework.