Medical Device Testing Solutions

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.

Comprehensive Testing for Regulatory Compliance

Navigating the regulatory landscape requires expertise and reliable testing solutions. We support your compliance with FDA, EMA, CDSCO, NMPA, and other regulatory standards, offering:

• Extractables and leachables (USP <1663>, USP <1664>)
• Cleaning and sterility (ISO 11135:2014, ISO 11607-1:2019, ISO 10993-7:2008)
• Biological evaluation - Identification of degradation products (ISO 10993)

Advanced Analytical Techniques

Our state-of-the-art instruments and techniques ensure precise analysis of metals, polymers, ceramics, and other materials. Key capabilities include:

• Metals and elements analysis (ICP-OES/ICP-MS)
• Material identification and characterization (FTIR, FTIR microscopy, STA, DSC, TGA)
• Thermomechanical properties (TMA, DMA)
• Optical properties (UV/Vis/NIR)

Specialized Solutions for Various Medical Devices

We provide tailored solutions for a range of medical devices:

• Orthopedic and Dental Implants: Raw materials characterization, surface analysis, failure testing.
• Contact Lenses: Drug delivery testing, solution testing, optical properties analysis.
• Surgical Meshes, Stents, Catheters: Extractables and leachables, thermomechanical properties, drug-eluting studies.