eQMS for small and mid-size device companies

Small and mid-size manufacturers outgrow a single spreadsheet without being ready for a year-long enterprise rollout. HAVGATE sits in that gap.

The symptoms are familiar. The quality lead is also the internal auditor. CAPAs live in a workbook. The supplier list is a tab. Training is a signature page at the back of the SOP. Management review is a slide built the night before. None of that means the QMS is fake. It means the links are in one person's head, and ISO 13485 clauses 4.2.4, 6.2, 7.4, 8.2.4 and 8.5.2 all ask for records someone else can follow.

Business plan pricing is 89 a month for up to 10 audit users, multi-site audit programs and branded reports, on top of the all-standards audit engine in Pro. Enterprise is a custom contract for the same audit platform. Use the trial on one real process — complaint handling or incoming inspection — and see whether the finding, the CAPA and the report stay attached. Invite a second user only on a plan that includes them.

Mid-size teams sometimes already have a document controller and a separate finance system. You can adopt the audit platform first. Document control, training and suppliers are their own modules, and they are not included in the audit-platform price. CRM and bookkeeping are optional modules, not a requirement to rip out tools that already work.

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