What I do on every engagement
I am the consultant you speak to on the scoping call and the person who writes, reviews and signs the deliverable. There is no handover to a junior team. When a laboratory, a clinical specialist or an IVD collaborator is needed, they are named in the scope before the work starts, and the page describing that service says so.
Authentcare Private Limited is the company. The work is mine.
How an engineer ends up in regulatory affairs
For four years I worked in semiconductor design verification at Synopsys India, writing SystemVerilog and UVM test environments for MIPI protocol blocks. Verification is a discipline with one question at its centre: for every requirement, where is the evidence that it is met, and can someone else follow the path from one to the other without asking you?
That question is the same one a notified-body reviewer, an FDA lead reviewer or a CDSCO assessor asks of a technical file. The subject matter is different; the method is not. A requirements-to-evidence matrix, a verification plan written before the test, systematic documentation that another engineer can audit — these moved with me into regulatory work, and they are why the first page of this website talks about traceability rather than approvals.
I want to be precise about what that background is and is not. It is a transferable method and a fluency with complex electronic and software systems. It is not medical-device electrical-safety, EMC or hardware-verification experience, and I do not present it as such. When a device needs IEC 60601 testing, the testing is done by an accredited laboratory; what I bring is the applicability matrix, the essential-performance reasoning and the review of the report when it comes back.
The regulatory training
The Graduate Certificate in Medical Device Regulatory Affairs from the National University of Singapore gave the regulatory framework its structure: how the EU MDR and IVDR, the FDA's premarket and quality-system rules, and the ISO 13485, ISO 14971 and ISO 10993 families relate to one another, and where they do not.
Since then the practice has concentrated where the work is most technical and the evidence most often argued over: biological evaluation under ISO 10993-1:2025, toxicological risk assessment under ISO 10993-17:2023, extractables and leachables study design under ISO 10993-18, and breathing-gas-pathway evaluation under the ISO 18562 series. That is the flagship service, and it is where I would ask you to test me.
Why Delhi, and why the EU, US and India
Indian manufacturers are going abroad, overseas manufacturers are coming to India, and the documentation standard that satisfies a notified body in Munich is the same one that should go to CDSCO in New Delhi. Working from Delhi with an EU-and-FDA-grade method means one file serves three markets, built once and sequenced sensibly. I keep Indian hours but arrange calls to suit yours.
Three things you should know before you contact me
- Every deliverable traces each statement to its requirement or source, carries a document identifier, a version, an issue date and a reviewer, and is reviewed a second time by me before it leaves. Where a project engages a separately named qualified professional, that independent peer review is recorded too.
- I use retrieval-grounded drafting tools that run on hardware I control. Nothing those tools produce leaves the practice unreviewed, and client documents are never used to train any model. The How we use AI page says exactly how this works.
- I do not guarantee outcomes. Regulators and notified bodies decide; I prepare the file so that their decision rests on evidence rather than assertion. The scope and limitations page lists what Authentcare is not.