Cleanroom facilities
Where the process requires it, production runs in cleanrooms: controlled environments with filtered air, specialised flooring and stringent hygiene protocols, maintained to prevent contamination of the sheaths during production.
Home/Quality & Compliance
Quality
Say less than you can prove.
Hospitals, distributors and regulators ask the same question in different words: what can you evidence? Here is what is true today.
Certification status
No certification is claimed on this page.
SUHA does not publish regulatory marks, registrations or approval numbers it has not been granted. When certifications are issued, they will be listed here with their scope, their issuing body and their reference number — and not before.
If your registration process needs a current statement of where the programme stands, ask us directly and you will get a written answer.
Status board
01
Quality management system
In development alongside the manufacturing programme.
02
Regulatory registrations
To be published here on issue, with scope and reference numbers.
03
Facility construction
Planned against local building codes, zoning regulations and safety standards.
Controls
The controls the site is built around.
These are specified as part of the facility programme — written down before construction so they can be verified afterwards.
Production environment
A spacious, well-ventilated and properly lit production area, laid out so the workflow runs cleanly and the working environment stays safe and comfortable.
Material and inventory control
A dedicated storage warehouse for raw materials, finished products and inventory, organised with shelving and racking so materials are traceable and easy to reach.
Utilities and infrastructure
Electricity, water supply, HVAC and waste disposal specified to support manufacturing, with infrastructure upgraded where the process requires it.
Safety and security
Fire detection and suppression, emergency exits, first aid stations, surveillance cameras, access control systems and perimeter fencing.
Building codes and permits
Construction and building design planned to comply with local building codes, zoning regulations and safety standards, with necessary permits and approvals obtained from regulatory authorities before construction activities begin.
What we will not do
Three things you will never find on this site.
01
Borrowed certification marks
No regulatory logo appears here until SUHA itself holds the certificate behind it.
02
Unsupported clinical claims
No performance figures, outcome data or comparative claims without a study to point at.
03
Decorative statistics
No production volumes, market shares or partner counts invented to fill a layout.
Let's move medicine forward
Ask the difficult questions.
Regulatory and procurement teams are welcome to interrogate the programme. A clear answer, including the word “not yet”, is more useful than a brochure.