New York, USA – October 29, 2021 – STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches risk assessments services for the medical device industry. It is used for the evaluation of potential risk problems that could be encountered in connection with the use of a medical device.
Biological hazards, risk characterization, and toxicological risk assessment are required to ensure the safety of a novel medical device and meet the requirements of marketplaces. STEMart now offers a series of risk assessments services, including the Toxicological Risk Assessment, Biological Evaluation Plan, Biological Evaluation Report (BER), Equivalency Assessment, and Gap Analysis. For example, in terms of Toxicological Risk Assessment service, STEMart’s experts team will help clients to use identified compounds and relevant biological testing to balance risks with the clinical benefit to the patient. It can provide hazard identification, dose-response evaluation, exposure assessment, and risk characterization.
For Biological Evaluation Report, STEMart will help customers to determine various aspects, such as biological evaluation of the medical device, the acceptability of the material for the intended purpose, the risk management plan, material characterization, the interpretation of data and results, additional data for the biological evaluation, and biological safety conclusion.
As for Biological Evaluation Plan (BEP), it is an initial risk assessment for medical devices. The general considerations for the BEP taken into account are the nature and duration of body contact, the selection and materials of construction, manufacturing processes, the biological endpoints of concern, and the historical use of the device. BEP supports a strategy to address areas of remaining biological risk, which may include both chemical and biological testing.
These new series of risk assessments services are a supplement to the biocompatibility testing services. STEMart offers comprehensive biocompatibility testing for both in vitro and in vivo assessments. With extensive expertise in biocompatibility testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks. It experts have years of experience in a variety of testing services for Class, I, II and III medical devices, and can provide assistance for customers to ensure that every aspect of medical device is properly inspected.
“We are glad to offer such new series of risk assessments services to medical device industry. Our team has considerable experience and looks forward to working with our clients. We will continue our commitment to providing high quality service and useful tools for the institutions and organizations we serve,” said Tina Frederick, Executive Director of Marketing at STEMart.
If you have additional questions about medical device risk assessments services or would like to find out more about the medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform with an expanded global footprint and has a broad portfolio of more than 10,000 products. It aims to provide best-in-class lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage towards the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer, and through that to accelerate access to better health for people everywhere.