Medical material testing is a critical component of the product development process and production quality control for medical devices, implants, and other healthcare products. By ensuring that materials are safe, effective, and compliant with regulatory requirements, these tests help to protect patients and healthcare providers and promote the delivery of high-quality healthcare services. The tests can include measures of tensile strength, elongation, compression, hardness, and other mechanical properties such as syringe glide force.
In addition to these physical tests, medical material testing may also involve regulatory compliance testing. This can include testing to ensure that the material meets the requirements of various regulatory bodies, such as the FDA or the EU Medical Device Regulation.
Having a high level of data integrity is of utmost importance within FDA regulated industries and for a good reason. Poor management of data integrity can result in quality gaps of the final product, which in the worst case can harm the user and for the company mean product recalls and risk of damaging the company's brand and reputation.
Data integrity is the accuracy, reliability, and consistency of data throughout its life cycle and there is an increasing attention to compliance with these requirements. The regulatory guideline on Data integrity according to FDA describes that the data should be attributable, legible, contemporaneous, original and accurate. It can be extremely time- and resource-consuming to comply with the above requirements for high data integrity if you do not choose the right systems to help you.
Watch the recordings from this webinar to hear about how our systems can help you maintain a high level of data integrity of your material testing data. You will have the opportunity to ask specific questions and meet our expert in the field.
Webinar content:
• A review of data integrity for FDA regulated industries
• What are the data integrity requirements?
• What are the main challenges?
• Which tools can we offer to help you?
• Questions and answers