The CanuSoft advantage of quality and product features is measurable and apparent to our customers as well as to our end users.

Our skill and expertise in medical device manufacturing helps in giving us a decisive advantage over most competitors.

Product/Quality
Attribute
The CanuSoft Advantage What to avoid in competing products
Needle Quality

Best-in-class, all-Japanese needle

Triple facet (back cut) as per ISO 10555-5

Lower quality needle from cheaper sources, or produced in-house with lack of validation

Lancet point needle not suitable for venipuncture
Catheter Quality

Best-in-Class catheters with European technology

Choice of PTFE, FEP or PUR

Wide range of sizes, from 12G to 26G

Restriction to one catheter material, irrespective of end-user preference

Limitations in producing 12G, 13G or 26G catheters

Inconsistent catheters from low quality sources

Needle & Catheter penetration force

Unique in-house technology to ensure extra-smooth and low-pain venipuncture

Usage of tools developed and maintained in-house for catheter forming and asenbly with needle

Dependence on third party technology for catheter forming and assembly, lack of reliable source for forming and assembly tools

High penetration force for needle and catheter

Inconistent fitment between needle and catheter due to improper forming of catheter tip

Flashback

Fully validated flashback

Option of flashback assisted with hydrophobic filter

Inconsistent flashback, leading to repeated insertions and failure

Non-availability of hydrophobic filter

Siliconization Robust in-house technology for siliconisation Arbitrary siliconisation methods, non-compliant with ISO-10555-5
Sterilization

In-house sterlization with ETO gas, validated and operated as per ISO 11135 and ISO 11138

All batches tested for sterility

Dependence on outside sterilizers, leading to risks of process compromises and higher lead times

Infrequent testing or re-validation of sterilization

Packaging

Wide choices of packaging with soft/rigit film, paper / tyvek, etc, all validated as per ISO 11607

Online printing to provide maximum flexibility and safety for OEM labels

Labeling and bar codes as per ISO 15223

Restrictions of packaging methods and materials irrespective of end-user preferences

Arbitrary or non-standard packaging materials or methods leading to risks of contamination

Dependence on outside printing for primary labels, leading to risks of contamination and improper labeling

Arbitrary methods of labeling or barcode control

Analytical testing

In-house laboratory for physico-chemical and microbiological testing

All batches tested for pyrogenicity

Dependence on outside laboratories, leading to risks of process compromises and higher lead times

Infrequent and unreliable testing

Biocompatibility

Ue of certified biocompatible materials

Biocompatibility tests as per ISO 10993-1

Choice of materials dependent on cost and availability rather than biocompatibility

Inadequate or incomplete testing for biocompatibility

Product features

Full service, in-house design and development

Unmatched flexibility for adding or modifying product features

Rapid prototyping for new product or variant launches

More than 20 different formats of IV Cannula available

Limitations in adding or creating new product features to suit user requirements

Restricted or fixed product range

Non-availability of critical product featuers (e.g. safely catheter) leading to ineligibility for entering user segments

Inability or long lead times for new product creation

Environment control

Manufacturing facility located in well-developed, no-polluting industrial area

Assembly and production areas validated and operated as per ISO 14644

Inadequate environment controls in assembly areas, especially injection moulding, component storage and product inspection
   
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