Global Compliance - Ready LSR Components: Custom Medical Silicone Solutions for OEMs

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Hey everyone! Let's face the facts. If you're in the market for silicone for catheters, implants, or diagnostic equipment, you're not simply purchasing parts. You're investing in risk management. I've witnessed far too many projects go off - track due to biocompatibility issues or gaps in MDR documentation. So, let's cut through all the unnecessary jargon.

The Compliance Minefield (and Your Shortcut)

Your LSR supplier should handle these for you:

- EU MDR 2017/745 & FDA 21 CFR Part 820: Complete traceability from the raw material to the finished product.

- ISO 10993 - 5: Cytotoxicity reports for your specific formulation. (General certificates won't work for implants.)

- UDI Requirements: Does your supplier keep records of every batch like this?

> Practical Tip: Demand test reports on extractables/leachables (E&L). I've had clients suffer because of plasticizers in 'compliant' silicones. See FDA Guidance

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More Than Just “Biocompatible” – Your Secret Performance Weapon

(Why LSR outshines TPEs/rubber)

Property	Medical LSR	TPEs
Compression Set	<10% deformation	25 - 40% deformation
Temp Range	-50°C to 200°C	-30°C to 120°C
Autoclave Cycles	100+ stable	Degrades after 20

(Source: MedTech Europe Materials Database)

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Real - world successes this enables:

- Drug delivery seals that remain leak - free after freeze/thaw cycles

- Surgical tool grips that can be sterilized daily without cracking

Customization: Where EXNAN Solves Your 3 Biggest Headaches

(Subtle product integration)

1. Precision that rubber can't match:

- ±0.05mm tolerances for microneedle seals using our in - house micro - molding.

2. Eliminate assembly steps:

- Overmold onto PEEK/plastic without primers – reduces labor (ask about our German client's 40% time savings Case Study.

3. Surface engineering:

- Having a fluid friction problem? Laser - textured micro - dimples in EXNAN - Sil™ reduce resistance by 60% compared to smooth LSR.

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⚠️ The “Gotchas” When Vetting Suppliers

(Partner Checklist Expanded)

Don't accept anything less than:

☑️ Class 8 Cleanroom Molding (Photo of EXNAN's cleanroom with ISO 14644 cert visible below)

☑️ Raw Material Control: USP Class VI resin, lot - specific FDA MAFs

☑️ Sterilization Validation Data: E - beam/gamma stability tables

☑️ Design Ownership: Can they approve this workflow?

Compliance ≠ Paperwork. It’s Speed to Market.

➡️ EXNAN customers get their products to market 9 weeks faster on average because we:

- Pre - validate materials to ISO 10993 - 17

- Store your device master file (DMF) for FDA access

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Your Move → Grab these resources and get back to R&D:

1. EU MDR/FDA Compliance Checklist for Silicone (Lead generation gateway)

2. Free Consulting Call: “Does my application need platinum - cure or peroxide - cure LSR?” Schedule a 15 - minute chat

> “EXNAN's ISO 18562 - 3 airflow cert helped us pass biocompatibility testing in one try.”

> — Lab Devices Lead @ Top 5 US MedTech OEM

References:

- RoHS/REACH Declarations:

- ISO 10993 - 10 Sensitization Testing Protocol

Contact Us

​Global Compliance - Ready LSR Components: Custom Medical Silicone Solutions for OEMs

The Compliance Minefield (and Your Shortcut)

More Than Just “Biocompatible” – Your Secret Performance Weapon

Customization: Where EXNAN Solves Your 3 Biggest Headaches

⚠️ The “Gotchas” When Vetting Suppliers

Compliance ≠ Paperwork. It’s Speed to Market.

References:

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Global Compliance - Ready LSR Components: Custom Medical Silicone Solutions for OEMs