Home · Capabilities
Manufacturing

Six capabilities, one process, no brokering

What we keep in our own hands is what we can change for you without renegotiating someone else's schedule.

01

Adhesive Formulation

In-house hydrocolloid, medical acrylic, hot-melt and soft silicone gel formulation. Peel strength, MVTR, residue and wear-time tuned per indication — not bought off a catalogue.

02

Precision Coating

Slot-die and gravure coating from 20 to 300 g/m², thickness tolerance held across the full roll width. Clean-room lamination for multi-layer constructions.

03

Die-Cutting & Converting

Rotary and flatbed die-cutting, kiss-cut on liner, slitting down to 3 mm, perforation and multi-up nesting. From jumbo roll to retail-ready sachet.

04

Printing & Surface

CMYK offset and flexo on skin-contact films, Pantone matching, foil, matte/gloss and functional inks — glow, thermochromic and colour-change.

05

Sterilisation & Packing

EO sterilisation with validated cycle and residual testing, pouch and blister sealing, retail cartoning. Sterile or non-sterile supply per your registration route.

06

Regulatory Dossier

Technical file, biocompatibility reports, material composition, ISO 10993 test data and traceability records — prepared to support your CE, FDA or NMPA submission.


Quality & regulatory

Quality & Regulatory

We publish status, not promises. Every line below reflects the actual certificate held; anything not yet obtained is marked open. Ask us for the current certificate pack before you write a claim into your artwork.

Certificate / system Scope Status
ISO 13485 Medical Devices QMS Design & manufacture of medical skin-contact products TBC
ISO 9001 Quality Management Whole-site quality system TBC
CE Marking (EU MDR 2017/745) Ostomy range, per device classification TBC
FDA Establishment Registration US market, per product code TBC
NMPA Registration (China) Domestic medical device registration TBC
ISO 10993 Biocompatibility Cytotoxicity, irritation, sensitisation TBC
REACH & RoHS EU chemical substance compliance TBC
EN71-3 Toy Safety (tattoo range) Heavy metal migration for children's products TBC
EU CPNP Cosmetic Notification Acne patch as cosmetic, where applicable TBC
Every row above is published as-is. TBC means we have not obtained it yet — not that it is implied. Request the current certificate pack before writing any claim into your artwork or listing.
In-house & third-party testing

What we measure

Every construction is released against physical and biological test data — not against a habit.

  • Peel strength & shear holding
  • Moisture vapour transmission (MVTR)
  • Fluid absorption capacity
  • Odour barrier performance
  • Cytotoxicity, irritation, sensitisation
  • EO residual (sterile supply)
  • Heavy metal migration (inks)
  • Shelf-life / accelerated ageing
OEM / ODM process

From brief to repeat supply

Four stages. No stage is skipped to close a deal faster.

01

Brief & indication

You tell us the use case, market, claim target and volume; we confirm the technical route and regulatory path.

02

Formula & sample

Adhesive and construction proposed, lab samples produced and tested against your acceptance criteria.

03

Validation & pilot

Pilot run on production equipment, process validation, documentation pack issued.

04

Mass run & supply

Scheduled production with batch traceability, COA per lot and export packing.

[ TBC ]Years in skin-contact manufacturing
[ TBC ]m² production area
[ TBC ]Patch units / month
[ TBC ]Export markets
Talk to engineering

Tell us what you want to put on skin.

Send us your product, drawing, sample or just an idea. We reply within two business days with a technical route, a realistic MOQ and a schedule.