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We build custom software, websites, AI tools and automation that help businesses work smarter. The eQMS for Medical Device Companies covers audits, CAPA, document control, training and suppliers for ISO 13485, MDSAP, EU MDR and FDA QMSR.

One platform, every quality process

The lead product is the eQMS. Audit management, CAPA, document control, training and supplier quality each have their own page and their own records. They connect where the regulations connect: an audit finding can open a CAPA, a CAPA can change a controlled document, and that document can assign training. MDSAP's seven-chapter checklist is included, not bolted on as a PDF.

Built for the standards you are audited against

ISO 13485:2016 and ISO 9001:2015 are first-class audit criteria. MDSAP follows AU P0002.010. EU MDR is in the same engine for the QMS evidence you sample internally. FDA QMSR is the US quality-system regulation aligned with ISO 13485, so teams are not keeping a second conflicting checklist. Starter audits one standard at a time. Pro and above can combine them in one session.

From finding to CAPA to closure

The report is not the end of the audit. HAVGATE keeps the clause or MDSAP task on the finding, the nonconformance on the finding, and the effectiveness check on the CAPA. Root-cause tools are 5 Whys and Fishbone. A person approves the cause and the report. Drafting assistance does not sign for you.

How the modules stay separate

HAVGATE is an eQMS for Medical Device Companies, plus business digitalization for the same teams. CRM and bookkeeping are separate modules in the same platform: a sales pipeline is not a device history record, and an invoice is not a CAPA. The links between a supplier invoice and an approved supplier, and between a CRM message and a CAPA, are not automatic yet. Items and bills of materials already exist inside quality change control. Custom software for other work stays on the services page.

Security, without invented certificates

The company is based at Utigenstrasse 7 in Central Switzerland. The security page states that product data is stored on Lovable Cloud in AWS US regions, with AES-256 at rest and TLS 1.3 in transit, on infrastructure from providers that publish SOC 2 Type II. Customer content is not used to train models. Read that page before you copy a sentence into a supplier questionnaire. There is no customer logo bar, because there are no customers to show.

Pricing and the free trial

The audit platform is live and can be purchased. Starter is 19 a month, Pro is 39, Business is 89, and Enterprise is custom. The same face value is billed in USD, EUR, GBP or CHF. The audit trial is 14 days, needs no credit card, and includes up to 3 audit reports. Those prices and the trial are for the audit platform only.