Finished Devices

Upholding confidentiality, Heraeus welcomes you to our facilities to work side-by-side with our engineers. The clinical and regulatory expertise we offer, combined with proven development and manufacturing excellence make us the right solution for your assembly or device. We are convinced that a flexible responsive collaboration will result in a product that works better for you and your customers.

Guidewire Tips

Heraeus offers fully integrated solutions with capabilities across the full spectrum of design, product/process development and documentation, Regulatory Affairs and high volume/low cost manufacturing.

With the experience of 13 US FDA 510(k) clearances and several product lines with EU CE Mark, Heraeus is able to facilitate getting your device to market quickly and more efficiently.

Heraeus employs teams steeped in medical device expertise. Our team understands the challenges that you face. A strong medical advisory group is maintained to supplement clinical expertise and to provide feedback on everything from product performance to long-term trends in clinical practice.

Finally, Heraeus offers the full range of in-house product performance testing to support the design and development process as well as compile the testing required to secure regulatory clearances and approvals. Doing this in-house, we are able to drastically reduce development and regulatory timelines.

Regulatory services

  • FDA device clearance (510(k), PMA, etc.)
  • CE marking (technical file preparation, post market activities, etc.)
  • Support in clinical trial approvals, clinical trial support and set-up and maintenance of quality management systems
  • For startup customers who do not yet have an ISO certified quality management system, we offer to hold regulatory approvals (e.g., CE mark) for products on behalf of our customers.

Performance testing

Creation and execution of performance test plans to support development activities and regulatory submissions are determined for each device manufactured by Heraeus Medical Components.

Testing is performed according to ISO, EN, DIN, ASTM and applicable regulatory standards, including FDA requirements (e.g., 510(k) submissions, IDE applications, etc.). The list below is a non-inclusive list of the major standards utilized in the development process of our devices.

  • ISO 11070 - Sterile, single-use intravascular catheter introducers
  • ISO 10555 – Sterile, single-use intravascular catheters
  • ISO 10993 – Biological evaluation
  • ISO 80369 – Small-bore connectors for liquids and gases in healthcare applications
  • ISO 25539 – Cardiovascular implants – Endovascular devices
  • ISO 11607 - Packaging for terminally sterilized medical devices
  • AAMI TIR28 - Product adoption and process equivalence for ethylene oxide sterilization
  • AAMI TIR42 - Evaluation of particulates associated with vascular medical devices
  • FDA Guidance documents for guidewires and catheters
    • Coronary, peripheral, and neurovascular guidewires - performance tests and recommended labeling
    • Intravascular catheters, wires, and delivery systems with lubricious coatings - labeling considerations
    • Premarket notification [510(K)] submissions for short-term and long-term intravascular catheters – guidance
    • Non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems - guidance for industry and FDA staff
  • Additional performance testing beyond listed standards
    • Torque-ability (1 to 1 rotation through tortuous anatomy)
    • Simulated use/trackability
    • Rail support (guidewires)
    • Tip shape retention
    • Lubricity and durability of coatings
    • Prolapse resistance/tip resiliency

For selected laboratory tests, such as biocompatibility, sterility, particulates, conditioning (e.g., aging, environmental, transport, etc.), and package integrity, Heraeus collaborates with external partners.