Frequently Asked Questions
Chemva was founded to provide a one-stop shop for medical device companies that need assistance with a variety of tasks including chemistry and materials selection, toxicological risk assessments and biocompatibility services, and root cause analysis.
As soon as you come up with a fresh device concept, being proactive in your awareness of materials is essential. Making the right material choice early on will help ensure that your device doesn’t become a hindrance to entering the market on time.
We have come across many incidents where our clients selected a “nonoptimal” material that resulted in undesirable leachable profiles in chemical characterization studies or subpar in-field performance.
Per the outlined ISO 10993 series, EU MDR, and US FDA, you must send the “final finished form of the device” that has gone through all the manufacturing steps, been placed in its finalized packaging, and been sterilized as projected for commercialization.
In other words, continuously aim for the ultimate completed state of the device, which encompasses the primary packaging, manufacturing process, and, when relevant, the sterilization method. The product to be tested should reflect how it serves the patient’s needs.
It depends on the assessed knowledge gap about materials safety for your specific device and the device type and nature of interaction with a patient.
To determine how you should proceed, gather all relevant information about the device and assess for any missing data. If you find data gaps, you must perform chemical and/or physical characterization. The specific data required depends on the device type and its intended use. In some cases, you may not need extensive chemical characterization if the device only touches intact skin and comprehensive supplier material data is already accessible.
Regrettably, there’s no full global agreement in the biocompatibility field. While the ISO 10993 standards serve as a fundamental reference for biological assessments, there are still variations. Therefore, it’s important to know the specific requirements of each market and tailor your Biological Evaluation Plan accordingly.
Certainly, we provide training that’s tailored to your unique requirements. We suggest a half-day training for all your employees, followed by a workshop where you can delve into discussions related to your products. Upon completion, each participant can receive an Attendance Certificate.