Medical Devices | Conformal Coating, Parylene & ProShieldESD

Reliable Protection for Life-Critical Electronics

Our solutions for medical devices using conformal coating and Parylene deliver biocompatible, repeatable protection
for implants, diagnostics, and therapeutic electronics. We apply ultra-thin, pinhole-free Parylene and sector-specific
liquid coatings under robust quality controls to help you meet regulatory expectations and device performance targets.

For background on medical guidance, see ISO 10993 biocompatibility and the
U.S. FDA medical devices resources.

• 🔎 Medical Devices Conformal Coating Challenges
• 🛡️ Medical Devices Conformal Coating & Parylene Solutions
• 📏 Standards & Compliance (ISO 10993 / FDA)
• 🔬 Medical Device Coating Process
• 📈 Benefits of Medical Devices Conformal Coating
• 🧩 Example Application / Case Study
• 🤝 Talk to an expert
• ❓ FAQs

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Medical Devices Conformal Coating Challenges

• Biocompatibility – Demonstrating material safety for patient contact.
• Cleanliness – Maintaining low ionic contamination for reliable operation.
• Repeatable thickness – Consistency on miniaturised, complex assemblies.
• Sterilisation resistance – Withstanding EtO, gamma, or steam processes.
• Traceability – Robust documentation and audit trail for compliance.

Medical Devices Conformal Coating & Parylene Solutions

Learn more about our medical devices conformal coating capabilities.

Standards & Compliance (ISO 10993 / FDA)

Our medical device coating work aligns with globally recognised frameworks and customer requirements:

• ISO 10993 – Biocompatibility evaluation (project-specific).
• FDA guidance – U.S. FDA medical devices (design controls, submissions).
• ISO 9001 – Quality management for process control and documentation.
• Customer specs – Materials, testing, and reporting to programme needs.

Medical Device Coating Process

1. Assessment & Selection: device use case, contact classification, risks, test plans
2. Masking & Prep: custom boots/shapes/tapes, cleaning & bake-out
3. Application: selective spray, dip, or Parylene vacuum deposition with controls
4. Cure & De-mask: UV/thermal cure, careful removal, touch-up as needed
5. Inspection & Test: thickness, adhesion/cross-hatch, ionic & visual inspection
6. Documentation: travellers, certificates, and final reports for audits

Benefits of Medical Devices Conformal Coating

• Biocompatible protection – Ultra-thin, uniform layers at low thickness.
• Reliability gains – Reduced failures and longer device life.
• Sterilisation-ready – Tuned materials and adhesion for required cycles.
• Scalable – Prototype to volume manufacturing.
• Traceable – Strong documentation and audit support.

Example Application / Case Study

Use case: Protective coatings for implantable pump electronics.

• Objective – Prevent delamination and moisture ingress across sterilisation cycles.
• Approach – Parylene C with adhesion promoter; cleanliness & ionic controls; thickness coupons.
• Result – Improved reliability and compliance readiness aligned with ISO 10993.

Talk to an Expert

FAQs

Which Parylene grade is best for medical devices?

Parylene C is common for moisture and chemical resistance; Parylene N suits optical clarity and fine features. Selection depends on device use and testing.

Can coatings withstand sterilisation?

Yes—material selection and adhesion promotion are tuned for the required sterilisation method (e.g., EtO, gamma, steam), then verified with representative testing.

How do you verify coating thickness and cleanliness?

Thickness is measured on coupons or components; ionic/cleanliness checks and visual inspection confirm process control and repeatability.