Regulatory Compliance Services
Medical device manufacturing is regulated by government agencies (FDA in USA, CE in Europe, and Ministry of Health and Welfare in Japan) and industry quality standards (ISO 14971, ISO 13485, ISO 10993, and cGMPs). Biomerics' experience in medical polymers can provide valuable services and help lower the risk to our customers as they navigate the regulatory arena. Our quality and engineering teams are familiar with the following industry requirements and processes:
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|Regulatory and Quality Processes and Services||
Our full-service quality lab and skilled technicians provide a wide range of material and device testing capabilities assisting our customers in both product development and quality assurance. Please contact us to learn how we can help you meet industry requirements.