Catheter Manufacturing
& CDMO
Capabilities

ISO 13485 Certified Catheter Manufacturing

Envaste is an ISO 13485 certified catheter manufacturer and CDMO partner. Every project — whether a device we designed ourselves or one transferred in from a client — runs under the same certified quality management system, with MDSAP alignment and MDR certification.

Assembly takes place in a validated ISO Class 7 cleanroom of 1,500 sq ft, split into two independent rooms so that unrelated programmes can run in parallel without cross-contamination risk. Gowning and material store areas are classified ISO Class 8. Process validation follows IQ/OQ/PQ protocols with statistical process control on dimensional outputs.

Our regulatory team supports clients with documentation packages for 510(k) submission, CE marking, MDR and MDSAP requirements — so the technical file is built alongside the device rather than reconstructed afterwards. See the ISO 13485 quality system in detail.

Catheter Design, Extrusion and Assembly in One Place

Buyers outsourcing a catheter programme usually have to choose between an extruder, a coating house, an assembly contractor and a packaging supplier — then manage the tolerance stack-up between them. Envaste runs those operations under one quality system, so dimensional responsibility sits with a single supplier from pellet to sealed pouch.

• •Precision extrusion — 2Fr to over 30Fr, multi-lumen profiles, multi-durometer and multi-layer jackets, compounding for radiopacity and lubricity
• •Reinforcement — braiding and coiling embedded directly into the shaft wall for torque transmission and kink resistance
• •Joining — reflow, laser welding, adhesive dispensing and UV curing
• •Surface — hydrophilic coating of shaft and balloon, applied and cured in-house
• •Finishing — cleanroom assembly, testing, labelling, pouch sealing and packaging

Materials in regular use include Pebax and PEBA, nylon, PET, PTFE, polyurethane, polyethylene and silicone, with stainless steel and nitinol for reinforcement and core wires.

Balloon Catheter, Access Sheath and Cannula Manufacturing

Balloons are formed in-house by stretch-blow moulding in non-compliant, semi-compliant and compliant configurations, with diameters from 0.5 mm to 50 mm. Process control targets consistent wall thickness, high burst resistance and low folded profile — the three properties that determine whether a balloon crosses a tight lesion or stricture and survives repeated inflation.

Access sheaths and cannulae use the same reinforced-shaft platform: a thin-wall extruded liner, embedded braid or coil, and a hydrophilic outer layer, finished with an atraumatic tip and a radiopaque marker where the procedure requires fluoroscopic confirmation. Negative-pressure and suction-assisted sheath constructions are produced on this platform for our own Manawa™ range.

Finished devices are assembled, tested, labelled and pouch-sealed in the ISO Class 7 cleanroom.

From Prototype to Scale-Up Production

Outsourcing a catheter programme generally follows the same path, whether the starting point is a sketch or a device already selling in another market.

1. Feasibility — clinical requirement translated into shaft geometry, materials and tolerance targets.
2. Prototyping — short extrusion runs and hand-built samples for bench evaluation and clinician feedback.
3. Design freeze and verification — dimensional, burst, tensile and coating durability testing against the specification.
4. Process validation — IQ/OQ/PQ on the production configuration, with SPC limits set from the validation batches.
5. Scale-up — transfer to routine cleanroom production, with labelling, pouch sealing and release under the ISO 13485 system.

A device transferred in from another supplier joins at the verification or validation stage, depending on how much of the existing design history file can be relied on.