Question 1

Which quality certifications does Universal Sutures hold?

Accepted Answer

Our Bengaluru facility operates under an ISO 13485 quality management system with CE marking and EU MDR (Regulation 2017/745) certification. Universal Sutures is the second Indian suture manufacturer to secure EU MDR certification, covering 13 product families including surgical sutures, bone wax and hernia repair devices.

Question 2

How are your surgical sutures sterilised and packed?

Accepted Answer

Sutures are needled on drilled-end ribbed needles, sealed in aluminium foil primary packs with a validated sterile barrier and terminally sterilised using validated ethylene oxide cycles. Each batch is released with a certificate of analysis covering tensile strength, needle-attachment pull, sterility and endotoxin limits.

Question 3

Do you support OEM and private-label suture programmes?

Accepted Answer

Yes. Our OEM division develops customised suture, mesh and bone wax ranges under your brand — including artwork, label languages, pack configurations, needle geometry selection and regulatory dossier support for CE, EU MDR and country-specific registrations.

Question 4

What tensile strength standard do your sutures meet?

Accepted Answer

Every suture and suture-needle combination is manufactured to at least 1.1 times the USP requirement for tensile strength and needle-attachment pull, providing a safety margin above pharmacopoeial minimums.

Question 5

How many product codes are available?

Accepted Answer

More than 5,000 active product codes cover suture materials, USP sizes, thread lengths, needle shapes and pack quantities, allowing distributors to consolidate an entire wound-closure portfolio with a single manufacturer.

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