The AI-nativecompliance partnerfor healthcare startups
Privacy, contracts, DPO, ISO, CE markingFiled correctly, signed by someone accountable
Bash Legal is the compliance function for healthcare startups.We are a team of legal and privacy specialists, and AI is the core pillar of how we operate. That is what lets us deliver a faster, better service, at a fraction of the price.
You get a DPO and a legal team, without hiring either.Terms and conditions. Privacy policies, the ROPA, retention schedules, and the Art. 9 legal basis for the health data you actually process.Data processing agreements, the sub-processor register, standard contractual clauses and the transfer impact assessment. A DPIA when the processing calls for one.We take the Art. 37 appointment, notify the Garante, and run the clock when a breach lands. You get 72 hours. We have done it before.
When a deal needs a certificate, we run it end to end.ISO, one standard at a time. CE marking for Class I devices: technical file, ISO 14971 risk file, clinical evaluation, labelling and IFU, declaration of conformity, Ministry of Health and EUDAMED.Software as a medical device usually sits a class above, where a Notified Body enters the process. We scope that with you before you commit to a date.We advise you on the best move and, once we agree, we deliver it for you.Ask us what is blocking your next enterprise deal, and we will be glad to help.
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