THE MANUFACTURING FACILITY
Green Med Ltd. is a UK legal manufacturer operating its own facility. Here we design, manufacture, quality-control and give final batch release to our product line in-house, under a single certified quality management system.
Porte Marsh Industrial Estate
Calne SN11 9PT, United Kingdom
THE FACILITY · 2,740 M² TOTAL
CAPACITY & PEOPLE
WHAT WE HOLD
- Holds design authority, technical documentation and brand rights
- Carries regulatory responsibility — registrations & Declaration of Conformity
- Owns the ISO 13485 quality management system
- Performs in-house manufacturing and quality control
INSIDE THE FACILITY
WHAT WE MANUFACTURE
Our own product line spans four categories — all designed, specified and released under the Green Med standard.
In-vitro diagnostic reagents and test kits developed and manufactured to our specifications.
Medical devices and medical equipment that Green Med designs, manufactures and places on the market.
Non-medical laboratory equipment engineered and built to defined performance and safety criteria.
Laboratory consumables and chemicals produced under the same controlled quality framework.
Manufactured vs. integrated OEM and third-party products are integrated or distributed — not manufactured by Green Med, and sit outside our manufacturing scope.
THE PRODUCTION PROCESS
Every product begins as a Green Med design — engineering and R&D define the specification, materials and performance criteria.
Documented under our ISO 13485 system — technical file, risk management and validation records — before production is authorised.
Raw materials and components come from qualified, agreement-bound suppliers and are inspected against defined criteria on arrival.
Manufacturing runs at our own UK facility, to the specification and controls set by our engineering and quality teams.
In-process and final quality control verify every batch against the Green Med standard, including IQ/OQ/PQ and cold-chain validation. Nothing moves forward until it conforms.
Packaged and labelled with the Green Med identity — including the legal manufacturer, batch and reference information — ready for release.
Every batch is reviewed and released in-house by Green Med Ltd., placed on the market under our own Declaration of Conformity. Nothing ships without our sign-off.
QUALITY SYSTEM IN PRACTICE
The process above describes what happens. These are the controls that guarantee it happens the same way, every time.
Our quality system is subject to periodic surveillance audits by BSI. Green Med Ltd. is registered with the MHRA and subject to its regulatory oversight.
Every batch is traceable from incoming raw material to the finished, released unit — full genealogy is maintained for every product we ship.
Non-conformities, complaints and audit findings feed a formal CAPA system — root cause is investigated and corrective action verified before a case is closed.
Our ISO 7 cleanroom is continuously monitored — particle counts, viable environmental monitoring and controlled gowning procedures keep production within defined limits.
Risk management runs throughout the product lifecycle — from design through production to post-market feedback — not a one-time exercise at launch.
Measurement and test equipment is calibrated on a defined schedule, with full calibration records maintained and traceable to national standards.
Critical materials are held in safety stock to protect production continuity, without compromising the qualification standard applied to every batch.
CERTIFICATIONS, STANDARDS & CONFORMITY
As the legal manufacturer of its own product line, Green Med Ltd. designs, documents and releases its products under a certified quality management system — and places them on regulated markets under the appropriate framework for each region and product risk class.
Green Med Ltd. operates a certified ISO 13485:2016 quality management system covering the design and manufacture of its product line — the basis for CE marking under the EU MDR and IVDR.
A certified ISO 9001:2015 quality management system underpins Green Med's business and operational processes alongside its medical-device QMS.
Products are placed on the market under Green Med Ltd., supported by UKCA and CE Declarations of Conformity.
Green Med Ltd. is registered with the UK Medicines & Healthcare products Regulatory Agency (MHRA) as a medical device manufacturer.
UKCA marking under the UK MDR 2002, supported by MHRA registration.
EU MDR (2017/745) and IVDR (2017/746), placed via an EU Authorised Representative with CE marking.
ÜTS (Product Tracking System) registration for the Turkish market.
Conformity assessment is routed by product risk class. Higher-class medical devices and IVDs are assessed by a UK Approved Body / EU Notified Body; lower-risk products are self-declared under Green Med's Declaration of Conformity.
Regulatory documentation, including our ISO 13485 certificate and UKCA/CE Declaration of Conformity, is available on request.