Get Medical Devices approved on time and on budget!
Welcome
My name is Hana, and I’m a medical device expert and toxicologist. My job and my passion is to provide you with expert advice on medical devices topics.
From helping you to understand regulatory requirements, through risk and biocompatibility assessment and study design, to executing testing protocols, I am ready to help you to pass your medical devices through the approval process worldwide.
From helping you to understand regulatory requirements, through risk and biocompatibility assessment and study design, to executing testing protocols, I am ready to help you to pass your medical devices through the approval process worldwide.
I am a participating member of ISO/TC 194 (various WG’s) and DIN NA 027-02-12AA committees and have an active role along with the regulatory committees developing standards, discussing biocompatibility methods, and voting on changes to those standards.
Services
No matter where you are located, and no matter where you are in the process, I can help you find that perfect balance between regulatory acceptance and cost.
✔ Evaluate the biocompatibility of your new device
✔ Assess the impact of a design change or new manufacturing process on your device’s safety
✔ Evaluate new raw material suppliers
✔ Consider effects of sterilization techniques or long-term material stability
✔ Generate toxicology reports
✔ Review the biocompatibility evaluations for your international regulatory submissions
✔ Establish biological safety plans and conduct gap analyses of existing biocompatibility dossiers
More information >
No matter where you are located, and no matter where you are in the process, I can help you find that perfect balance between regulatory acceptance and cost.
✔ Evaluate the biocompatibility of your new device✔ Assess the impact of a design change or new manufacturing process on your device’s safety
✔ Evaluate new raw material suppliers
✔ Consider effects of sterilization techniques or long-term material stability
✔ Generate toxicology reports
✔ Review the biocompatibility evaluations for your international regulatory submissions
✔ Establish biological safety plans and conduct gap analyses of existing biocompatibility dossiers
More information >