In BioAplicada we provide advice and cooperate with the design of a comprehensive testing strategy so that your product can reach the certification and commercialization stages fulfilling all the biocompatibility and safety requirements.
Reviewing and selecting biocompatible raw materials and supplies to ensure the production’s safety. The right selection of materials and processes that will be used to produce a medical device reduces the time and costs of the product’s certification.
Product Risk Analysis
The product risk analysis includes a series of processes by which the manufacturer can identify potential hazards related to the product and its accessories, estimate and evaluate the associated risk to be able to control it and monitor how effective the controls are.
Risk analysis is based on objective evidence obtained by observation, quantification, testing and other means, and can also be enhanced by bibliography and the device`s historic records.
The goal is to prove that the benefits of a certain medical device outweigh the risks of it`s use, if any, making the registration process easier.
Biocompatibility testing in finished medical devices for the Product Certification
The goal of these tests is to evaluate the biocompatibility of the devices in their final presentation, which is to say in the way they will be commercially released, measuring the biocompatibility of all processes and its interactions (materials, productive processes, cleaning processes, sterilization, etc).