MD Access Consulting | العربية
Medical device quality systems, sterilization validation, and market access.
Twelve years of building ISO 13485 systems, validating sterilization on the factory floor, and preparing manufacturers for inspection — working in Arabic and English.
ISO 13485:2016 · ISO 11137 · 21 CFR 820 / QMSR · ISO 14971 · UDI / GUDID · GS1 US · JFDA
Services
Four places manufacturers get stopped.
Each is governed by a named standard. We work to the standard, not to a template.
ISO 13485 · 21 CFR 820 / QMSR · ISO 11137
Quality management systems
Gap assessment, documentation build, internal audits, and readiness for certification or FDA inspection. Sterilization validation to ISO 11137 — dose establishment, dose mapping, and the periodic dose audits that keep a validation from quietly expiring.
Since February 2026, FDA inspectors can review management reviews, internal audit reports and supplier records that were previously protected. Most systems were not built with that in mind.
UDI · GS1 US · GUDID
Device identification
GS1 company prefix and GTIN allocation, label design, and submission to GUDID. Procedure packs and convenience kits carry identification obligations that most manufacturers discover only when a submission is rejected.
JFDA
Jordan market registration
Product registration and technical documentation for the Jordanian market. Classification, dossier preparation and submission — prepared the way JFDA actually expects, in Arabic and English.
JFDA · Jordan
Wound care market entry
Classification, registration and market guidance for wound care products entering Jordan — dressings, advanced wound care and related consumables. Regulatory pathway and commercial positioning together, since in this category they decide each other.
Who we work with
Manufacturers, distributors, and the people who move product into regulated markets.
Single-use sterile devices, wound care and disposables — syringes, IV sets, catheters, dressings, gowns, drapes, sutures and procedure packs.
About
The person you meet is the person who does the work.
MD Access Consulting is built on more than twelve years inside medical device quality and regulatory work — building ISO 13485 systems, running sterilization validations on the factory floor, and preparing manufacturers for inspection.
Large firms sell you a partner and send a junior. We are deliberately small. Engagements are led and delivered by the same person, in Arabic or English, against your regulator’s actual requirements rather than a generic checklist.
Where a project needs expertise outside our scope — ethylene oxide sterilization, biocompatibility testing, clinical evaluation — we bring in named associates rather than improvise. You will always be told which is which.
Credentials
12+ years — medical device quality and regulatory affairs
ISO 13485 — lead auditor training, with FDA 21 CFR 820
ISO 11137 — dose mapping, dose setting and dose audits
UDI — GS1 US implementation, GTIN allocation and labelling
AR / EN — documentation, training and audits in both languages
Free resource
The FDA QMSR gap checklist.
What changed when 21 CFR 820 adopted ISO 13485, which records became open to inspection, and the clauses most quality systems fail on. Written for QA managers, not for marketing. Sent by email, no charge.
Contact
Tell us what your regulator is asking for.
An initial call costs nothing. If the work sits outside what we do, we will say so and point you to someone who does it.
Email info@mdaccessconsulting.com