Three doors.
One lifecycle.
Most clients arrive with a regulatory question, stay to build the product, and let us digitize the operations around it. Start at whichever door matches today's problem — the rest of the lifecycle is already under the same roof.
Quality & Regulatory
Regulatory strategy and approvals for active medical devices and combination products — monitoring, diagnostics, SaMD and digital health. QARA built from systems engineering, ISO 13485:2016 at the backbone — US FDA, CDSCO, Health Canada and IMDRF-aligned markets. India to the world, the world to India.
Quality & Regulatory →Product Engineering
Multidisciplinary, cross-functional systems engineering — nine disciplines and a five-phase methodology from systems definition to manufacturing support, built for mission-critical instrumentation.
Product Engineering →Digital Transformation
ISO 13485-ready Odoo ERP implementation, process automation and web development — operations as compliant as your product.
Digital Transformation →01 — HOW THE DOORS CONNECT
Small engagement. Long relationship.
Start compliant
Most engagements open with a regulatory question — a classification, a document review, a market-entry plan.
Build the product
The same team that wrote your regulatory strategy engineers the product — with the audit in mind from the first schematic.
Run the operations
ERP, automation and web that keep the business as compliant as the device it ships.
NOT SURE WHICH DOOR?
Just ask.15 MINUTES — WE'LL POINT YOU RIGHT, EVEN IF IT'S NOT AT US