Medical Device Testing
Chemika has been serving Australian manufacturers for nearly 20 years, offering a high quality, independent chemical testing laboratory service. We have an outstanding team of scientists that bring breadth and experience from around the world. Our experience covers a diverse range of international compendial methods for chemical analysis including BP,EU, JP, USP as well as customer supplied methods.
Medical device testing calls for a different approach to quality control and regulatory testing, compared to the requirements of medicine manufacturers. Manufacturers of medical devices rarely have the luxury of published monographs applicable to their specific product. Each product is different and regulatory affairs requires strong scientific support to achieve quality and regulatory objectives. Chemika is well equipped to work with clients to achieve their objectives, and display genuine scientific curiosity to achieve the most cost effective and elegant solutions.
Our experienced scientists will take the necessary time up front to ensure we understand your requirements, from preparing protocols, validation reports and to giving advice on international compliance where appropriate. Using a modern risk assessment approach, we will work with you to find a cost effective solution to meet your regulatory requirements and your production deadlines.
Services we provide:
Chemika has worked hard to become the independent chemistry laboratory of first choice, our commitment to quality drives us to solutions that meet the most stringent of international regulatory requirements.
Working with Chemika, you’re supporting a team with principles, dedicated to meeting your goal of improving the health and wellbeing, of all people, with nearly 20 years of experience in the area of chemical testing. Delivering results when you need them.
We look forward to hearing from you. Please contact us now to discuss your chemical analysis requirements.