With the combination of experienced analytical scientists and a rigorous
quality program, Impact Analytical has become a major supplier of analytical
service to the medical device industry. Our scientists have expertise analyzing
a wide range of sample types; including plastics, raw materials, chemicals,
contaminants, and gases. Impact’s quality program includes a full-time quality
manager, a 4-person audit team, and an experienced QAU (quality assurance unit).
Impact is ISO 9001:2000 certified, and GLP/cGmP compliant. Services offered to
the Medical Device industry include:
- Material Identification
- Product Deformulation
- Contaminant Identification
- Production Problem Solving
- Regulatory Testing
- Methods Development and Validation
- Raw Materials Analysis
- Thermal/Mechanical Properties Measurement
- Gas Analysis