Built by people who've
done the work.

We are a lean, specialist consultancy — not a generalist firm that does medical devices among fifty other things. Every engagement is handled by consultants with direct, hands-on experience in the standards, regulations, and testing processes we advise on.

Our work spans CDSCO registration, BIS certification, CE Mark technical documentation, IEC 60601-series compliance, ISO 13485 QMS, IEC 62304 software lifecycle, and testing coordination — in India, Europe, and internationally.

IEC 60601 is the foundational safety standard for medical electrical equipment. It defines what it means for a powered medical device to be safe and effective — and it's the standard most of our clients eventually encounter, regardless of their device type. The name is deliberate: we know the standard well enough to name the firm after it.

We work as an embedded extension of your team — not as external advisors who appear for meetings and disappear. We join your communication channels, attend design reviews, review documents in-draft, and give you direct access to the person doing the work, not an account manager.

Engagements are scoped clearly upfront. We quote for the deliverable, not the hour — so you know what you're getting and what it costs.