Ensuring the safety, durability, and efficacy of medical devices is crucial in the healthcare industry. At PerkinElmer, we offer comprehensive analytical solutions to meet these needs. Our accurate, reliable, and compliant solutions support medical device manufacturers in producing safe and effective products, from orthopedic and dental implants to contact lenses, sutures, stents, surgical meshes, and heart valves.
Testing for extractables and leachables is a fundamental step in developing safe medical devices. Our solutions help identify potential contaminants that may leach from materials, ensuring the safety and compliance of your devices with regulatory standards such as ISO 10993-18 and USP <1663> and <1664>.
Navigating the regulatory landscape requires expertise and reliable testing solutions. We support your compliance with FDA, EMA, CDSCO, NMPA, and other regulatory standards, offering:
Our state-of-the-art instruments and techniques ensure precise analysis of metals, polymers, ceramics, and other materials. Key capabilities include:
We provide tailored solutions for a range of medical devices:
Ensure compliance with regulatory requirements using our 21 CFR Part 11 compliant software. Features include: