Skip to content
ISO 14644-1 ISO 13485 EN 1822-1
+33 4 78 53 22 18
Request a Compliance Audit
§01 / Direct Channel — Compliance Engineering

Request a Compliance Audit

A scoping engagement with our clinical engineering desk — not a sales call. We review your facility's existing HEPA and contamination-control posture against ISO 14644-1, EN 1822-1:2019, and ISO 13485 baselines, then return a written gap report within 4 business hours of submission.

Median response time: 3h 41m across the last 90 audit requests
§02 / Audit Request Form

Submit Your Audit Request

A scoping intake — not a quote form. We use these inputs to pre-assign the right clinical engineer to your facility and to bring the relevant ISO/EN baseline to the first conversation. Fields marked with an asterisk are required for triage; everything else accelerates response time.

§03 / Field Engineering Network

Regional Engineering Offices

Each office carries a licensed clinical engineering team and on-site calibration stock — audits begin in-region, not from a remote sales desk. Below is the working coverage as of Q1 2026.

01
HEADQUARTERS

Lyon, France

14 Rue des Capitaines
69003 Lyon, France
02
MENA · EAST

Dubai, UAE

Office 1208, Business Bay Tower
Dubai, United Arab Emirates
03
LATIN AMERICA

São Paulo, Brazil

Av. Paulista 1842, 11º andar
São Paulo, SP 01310-200, Brasil
04
MENA · GULF

Riyadh, Saudi Arabia

King Abdullah Financial District
Riyadh 11564, Saudi Arabia
186
Personnel across 11 countries
1,412
Healthcare facilities served since 2007
42
Licensed clinical engineers in-house
96.4%
Client retention, rolling 5-year cohort
§04 / Documentation Footnotes

Before You Submit

Five recurring questions from facilities directors and procurement leads. The full engagement protocol is available on request after the scoping call.

  1. Is the audit confidential — and what happens to our facility data?

    Yes. Every audit request is opened under a mutual NDA before any technical exchange. Submitted form data is stored in our Lyon compliance ticketing system, accessible only to the assigned clinical engineer and the compliance desk. We do not anonymize facility data into case studies without a separate written authorization, and we never list client names publicly.

  2. Is the compliance audit free, or is it a paid engagement?

    The initial scoping audit is free of charge for qualified healthcare buyers — typically a 90-minute remote walkthrough and a written gap report delivered within 4 business hours of submission. A full on-site certification audit (11-day median turnaround, conducted by our in-house clinical engineers) is a paid engagement, quoted after the scoping call against facility size and system complexity.

  3. What standards does the audit evaluate against?

    Every audit is evaluated against three baseline references, which we hold simultaneously as a firm: ISO 14644-1 (cleanroom classification), ISO 13485 (medical device quality management), and EN 1822-1:2019 (HEPA/ULPA filter performance). Pharmaceutical clients additionally receive an ISPE-aligned baseline review, on request.

  4. Who actually shows up on-site if we proceed?

    An EcoMedPollutec clinical engineer licensed in your jurisdiction — never a subcontractor. Of our 42 in-house engineers, 9 hold European Registered Microbiologist credentials, and all carry terminal calibration certificates traceable to ISO 17025 reference standards. The scoping call tells you exactly who will lead the on-site work before any commitment.

  5. How fast will you respond, and what does the response look like?

    A qualified engineer or our compliance desk responds within 4 business hours of submission, median 3h 41m across the last 90 requests. The first response is a written gap report (PDF, ~12 pages) and a proposed audit window — not a sales deck. You are free to share the report with your procurement office before any further step.