Medical Devices

Medical Devices

Experience, dedication and strong fundamentals go a long way in shaping a successful product.

The engineering team at Prodenc has extensive experience of working with top medical device manufacturers on some of the most complicated and sophisticated medical devices found today.

As an amalgamated mix of experts with an exceptionally professional approach and customer focus, we deliver power and transformative solutions that are benchmarks for the industry.

Our areas of expertise include

1. Regulatory, Quality & Compliance

  • QMS alignment with ISO 13485 and FDA 21 CFR Part 820, including gap assessments, remediation strategies and implementations.
  • Preparation and maintenance of Technical Documentation to support EU MDR 745 / 2017 compliance and smooth interactions with Notified Bodies (e.g., TÜV, DEKRA).
  • Comprehensive audit readiness programs for internal, supplier, and Notified Body audits.

2. Materials & Biocompatibility

  • Identification and qualification of DEHP-free and alternative materials, supported by robust equivalency justifications.
  • End to end ISO 10993 biocompatibility evaluations, covering in vitro, in vivo, and material characterization studies.
  • Breathing gas pathway evaluations per ISO 18562 series, with strategic control of VOCs, particulates, and Leachables.

3. Sterilization, Packaging & Shelf Life

  • Expertise in sterilization modality selection and validation, including Ethylene Oxide (EO), Gamma irradiation, E-beam, Steam, and Vaporized Hydrogen Peroxide (VHP).
  • Medical device packaging design, verification, and validation, including shelf-life and stability studies in accordance with ISO and ASTM standards.

4. Injection molded part development and qualification

  • Requirements definition DFM: Define CTQs/tolerances; run DFM/Moldflow, material selection with sterilization/ISO 10993 considerations.
  • Tooling strategy build: SOW and supplier selection and approval of 2D/3D tool design.
  • DOE and Process Development: DOE to establish a validated process window and execute T0/T1/T2; dimensional/visual checks.
  • Metrology validation: GD&T plan, FAI, GR&R or TMV, and IQ/OQ/PQ on molding machine.
  • Release control: Freeze parameters; update PFMEA/Control Plan/WI/inspection plans; implement SPC/Cpk targets, and tool PM/spares.
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