Biological Evaluation of Medical Devices
Biological Evaluation
We provide you with everything you need to plan, test, and document compliance with ISO 10993-1. This is a crucial step toward securing a CE Mark certificate and getting your medical device to market in the EU and beyond.
Reusable Medical Devices
We can help you design validation studies of your cleaning, disinfection, and sterilisation procedures that ensure the safety of your reusable medical devices and their compliance with relevant guidelines such as AAMI TIR12 and ISO 17665.
Materials Screening
We can help you select and evaluate your medical devices construction materials for suitability and compliance readiness with regulatory requirements.
Change Management
We can help you evaluate the impact of design and manufacturing changes on your compliance with ISO 13485 and 14971 regulatory safety requirements.
Device-Drug Safety
We provide you with everything you need to test and document device compatibility with drug products in compliance with regulatory requirements.
Breathing Gas Pathways
We can help you plan, test, and document compliance with regulatory requirements and get your breathing gas pathway products ready for CE Mark certification.
In Vitro Diagnostics
We help you ensure that your in-vitro diagnostic medical device complies with (EU) 2017/746 (IVDR) Annex I and is ready to be certified with a CE Mark.
Stent and Implant Safety
We can help you get your stents and implants ready for CE Mark certification with our expert understanding of the ISO 10993-1 standard.