DeepMedic Pharma Pte Ltd · UEN 200417298M · SGX Mainboard: DMPH
We are audited so that our customers pass theirs. Thirty-one customer audits and four notified-body assessments in FY2025 — no critical findings.
FY2025 audit record
Thirty-one customers audited us in 2025. Four notified-body assessments. Two major findings, both closed within the agreed window; no critical findings. We publish these numbers because a supplier who only tells you about the clean years is telling you nothing.
The logic is simple. When your inspector opens a deviation on our machine, the supplier documentation is the first thing they read. If it is thin, you spend the next six months writing justifications for a design decision someone else made. Our job is to make sure that conversation is short.
The frameworks
Certificates we hold, and the regulatory frameworks our designs are built to satisfy even where no certificate exists.
Certified
Quality management for medical device design and manufacture. Held since 2009, covering all Singapore and Malaysia manufacturing. This is the certificate that lets us sell into the device and hospital channel rather than only to drug makers.
Design basis
The revised Annex made contamination control strategy a design obligation rather than an operating one. Every aseptic platform we sell is built to be defensible under it — including the ones we launched before 2022, which were re-assessed and, where necessary, changed.
Design basis
Electronic records and signatures. Audit trails that cannot be switched off, user access under your control not ours, and time synchronisation to your plant's source. Applies to every platform with a screen, including the vision modules.
Certified
Large steam sterilizers. Held on the DM-SR platform since 2010. Type testing and works testing, with the air detector and Bowie-Dick performance demonstrated on each shipped chamber rather than on a type sample.
Practice
Our software lifecycle. Category assessment, risk-based verification, and a build hash tied to the machine serial number and archived for twenty years. When a firmware question arrives in 2038, we will know exactly what was on your machine.
Certified
Bioprocessing equipment construction and welding qualification. Surface finish, drainability, dead-leg limits and orbital weld procedure qualification — verified by borescope and recorded weld-by-weld at our Senai fabrication centre.
Validation
Our validation team reports to the Board's Quality Committee. Their bonus is not linked to shipment dates. This is deliberate, and it is occasionally expensive.
Common questions
Yes, and we would rather you came. We host customer audits at Tuas and Senai on four weeks' notice, and we will share notified-body assessment reports under NDA. If you want to audit a specific platform's design history file, tell us which serial number and we will have it out of the archive.
The engineers who designed the machine. Not a technical-writing subcontractor, and not a template with the model number swapped. This is slower and it is the main reason our factory acceptance testing runs longer than the industry norm.
We fund the redesign. You re-qualify the change, because you must — but you do not pay for our supply chain's problem. Fourteen such redesigns since 2016, mostly PLCs on the sterilizer platform, where twenty-year-old machines outlive their controllers.
Sometimes. We declined nine orders in FY2025 because the window did not leave room to re-run challenge cycles on the actual unit. We will tell you at quotation stage rather than at week thirty-eight, which is a different kind of honesty from the one you are used to being sold.
Every platform with a screen ships Annex 11 and Part 11 compliant: audit trails that cannot be disabled, user access administered by you, and time synchronisation to your plant's source rather than ours. For older DeepMedic machines, our retrofit programme brings a 2007 controller into a 2026 data-integrity regime without replacing the chamber.
Within one business day of discovery, to every affected customer — including customers who would probably never have noticed. Three field notices in FY2025, all three self-identified rather than customer-reported. We publish that count annually whether or not it flatters us.