One device, multiple markets — done in parallel.

Single-market regulatory submissions are relatively linear. Multi-market programmes fail when each market's submission is prepared independently, producing inconsistent device descriptions, diverging risk management files, and clinical data that is structured for one regulator and has to be reformatted for the next. The result is delays, re-work, and queries that could have been avoided.

A well-structured global programme starts with a Master Technical File (MTF) or Design Dossier that is regulator-agnostic at its core — device description, design history, risk management per ISO 14971:2019, biocompatibility per ISO 10993, and performance testing — and then generates market-specific submission artefacts (SUGAM dossier, EU MDR Annex II file, FDA eSTAR) from that common source. We design the MTF architecture before any writing begins.

We also manage the regulatory calendar across markets. CE technical review, CDSCO review, and FDA 510(k) review run in parallel, with AI/query responses for each handled by the same team that built the dossier. This prevents the common failure mode of a multi-market programme where the team that built the file is no longer available when the regulator asks questions eight months later.

Each major regulatory system has requirements that do not exist in the others. EU MDR demands a PMCF plan and periodic safety update reports (PSURs). CDSCO requires an Essential Principles Checklist to Schedule III of MDR 2017 and may require bridging data if the device was not tested to IS standards. FDA requires a 510(k) summary and eSTAR format, and its performance testing standards sometimes differ from IEC equivalents accepted by EU notified bodies.

We maintain a working knowledge of all three systems and their current review practices, not just the published requirements. This means we know what FDA reviewers are currently asking about software safety for specific device types, what CDSCO is querying on Class C submissions, and which EU notified bodies have the shortest technical review queues for your device category.

Regulatory clearance is not the end of the programme — it is the beginning of post-market obligations that differ by market. In Europe, PSURs are due annually (Class IIa, IIb) or every two years (Class III), the PMCF plan must generate data, and EUDAMED registration must be maintained. In India, the import licence must be renewed and any change to device specifications, labelling, or manufacturing site requires CDSCO notification. In the US, Changes or Modifications to Existing Devices may require a new 510(k).

We provide post-clearance regulatory maintenance services, covering PSUR drafting, PMCF data collection oversight, CDSCO renewal and change notification filings, and FDA change impact assessments.