Certified QMS
ISO 13485:2016 and ISO 9001:2015 systems govern design control, purchasing, production, and post-market surveillance.
Regulatory & quality
Quality & compliance
Certified manufacturing processes that meet international regulatory expectations for medical devices.
Every EPMD device ships under a documented quality management system. We publish our certification posture openly so hospitals, distributors, and OEM partners can verify how we work.
Certificates
Certifications & marks
Core certificates that govern design, production, and market access.
- ISO 13485:2016
- CE Marking
- US FDA
- ISO 9001:2015
- CDSCO
Certificate PDFs and notified-body details are available on request. View downloads
Pillars
How we assure quality
Four pillars that keep engineering claims checkable and production repeatable.
Regulatory readiness
CE marking pathways, CDSCO registrations, and documentation packs prepared for US FDA submissions where applicable.
Full traceability
Component-level lot tracking from incoming inspection through finished-goods release for every medical device shipped.
Optical & electrical QA
Photometric benches, electrical safety testers, and burn-in cycles validate illuminance, CRI, and generator output before release.
Process
From design to release
A controlled path from concept through authorised finished-goods release.
Design controls
Risk management to ISO 14971, design reviews, and verification protocols before production release.
Incoming inspection
Qualified suppliers, certificate of conformance checks, and sampling plans for critical optical and electronic parts.
Controlled manufacturing
Cleanroom assembly, calibrated tools, and work instructions with electronic batch records.
Final release
100% functional test where required, packaging verification, and authorised person sign-off.
Need certificates or an audit slot?
Need a certificate pack, supplier questionnaire, or factory audit slot? Our quality team responds within one business day.
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