Services: Biocompatibility
QA Consulting works with each client and device to develop the regulatory and technical basis for test omission, test requirements, protocols, lab selection and reports. Testing ranges from screening of new materials to pre-market safety, product release and periodic audits.
Whether you’re changing an existing device or you’re developing an entirely new product, a systematic approach to the biological evaluation of your medical device is necessary. In accordance with international standards, biological evaluation of medical devices and any or all of their materials must be structured within a risk management process.
At QA Consulting, our consultants will help you formulate a biological evaluation program with a risk management process in accordance with ISO 14971 and we will help you determine what you must evaluate and the best method for that evaluation.
What standards must be adhered to when implementing a biological evaluation program within a risk management plan?