Medical Device Component Testing

Compliance with national and international standards for medical devices can be complex. From understanding material composition to failure investigation studies for possible contaminants, a trusted testing partner is key. Choosing your outsourcing partner involves many factors; from experience to leading edge technology, Impact Analytical leads the field. With the combination of experienced analytical scientists and a rigorous quality program, Impact has become a major supplier of analytical services to the medical device industry. We base our approach on your needs; utilizing a consultative approach to identify solutions based on regulatory requirements. Our scientists have expertise analyzing a wide range of sample types, including, but not limited to plastics, raw materials, chemicals, & contaminants. Impact Analytical’s quality program includes an experienced quality assurance unit (QAU) to support studies compliant with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) regulations. Whether you need full time support or extra capacity during peak workloads, Impact Analytical is here to support your needs. Impact Analytical has expertise in testing compliant to a variety of national and international standards pertaining to testing of raw materials and finished product. From material characterization to confirm biocompatibility to testing of raw materials (for identification or purity) and lot release testing, Impact Analytical can support you in your testing needs throughout the life cycle of your product

网站

https://www.impactanalytical.com

Medical Device Component Testing的外部链接

所属行业

制药业

规模

11-50 人

总部

Midland，Michigan

创立

1995

领域

Medical Device Testing、Biotechnology、Pharmaceutical Testing、Leachables Testing、Extractables Testing、Stability Testing、Biocompatibility、Raw Materials Testing和Lot Release Testing