eQMS software for medical device startups

A startup QMS has to be real enough for a notified body or an auditor and small enough that two people can run it. HAVGATE is built for that size: audits, CAPA, and the records around them, with a price on the page.

Early device companies often delay the QMS until a design partner or an investor asks for it. The delay is expensive if the first audit is also the first time anyone writes a procedure. You do not need every process of a 400-person manufacturer. You do need clause 4.1 and 4.2 documentation, a way to audit it, a way to correct it, and supplier control for whoever is building the device for you. Training records matter as soon as a second person touches product.

HAVGATE Starter, at 19 a month, is the published entry for a solo auditor or consultant: one standard per audit, up to 10 audits a month, PDF reports. Pro, at 39 a month, is the point where a startup covering ISO 13485 and EU MDR, or 13485 and MDSAP, can put both in one session. The 14-day trial needs no card and includes up to 3 audit reports. Those prices are the audit platform only.

Design control and clinical evidence still live in your files. HAVGATE does not pretend to be a design-history product. Use it to audit that file, to control the procedures, and to run CAPA when the audit finds a gap. CRM and bookkeeping are available as separate modules when you are also trying to track customers and invoices. Keep quality records out of the sales pipeline.

Do not buy software to decorate a pitch. Buy it when you will enter real audit notes during the trial. The sample report shows the output format with fictional data. There are no startup logos on this page, because HAVGATE does not have customers to name.