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Medical Devices/ IVD

FDA Guidance ISO 10993

FDA Guidance ISO 10993

We evaluate the biocompatibility of your medical devices in line with ISO 10993. Risk based selection of required tests, preparation of a final report.
Biocompatibility Testing for FDA (ISO 10993 1-33 Testing)

Biocompatibility Testing for FDA (ISO 10993 1-33 Testing)

HTW Lab has a full range of capabilities for biocompatibility testing in accordance with ISO 10993 (Biological Evaluation of Medical Devices). Talk to our experts about the biocompatibility testing for non-active medical devices such as personal protective equipment(PPE), disposable medical products, dental materials and surgical instruments.
Microbiological Testing

Microbiological Testing

Microbiological testing of a medical device refers to tests for the presence and risk of microbial contaminants. Methods may include testing of bioburden levels, presence of endotoxin, and methods for sterility assurance.
Medical Device Testing and Certification

Medical Device Testing and Certification

HTW Lab can guide you through the testing process step by step for your medical device products, and help you meet regulatory standards for global market access.
Personal Protective Equipment (PPE) Testing

Personal Protective Equipment (PPE) Testing

Personal protective equipment (PPE) used in work environments as well as leisure activities must meet high quality standards to effectively ensure human safety. This makes it all the more important that protective shoes, clothing and gloves, sports helmets, and swimming aids meet regulatory requirements proving particular safety functions. Understanding and meeting the regulations relevant to your PPE products in all of your target markets can be especially difficult during a time of crisis. It requires both technical expertise and industry know-how to navigate regulatory complexities and bring your PPE products to market quickly.