Analytical Testing
Medical Device Textiles and Biomaterials Solutions
Secant Group’s textile design approach starts with raw material selection and analysis, ideally at the earliest stages of development. This enables manufacturers to acquire robust data early to proactively mitigate risks and prepare for the regulatory submission process. It also ensures quality and consistency within Secant’s own raw material supply chain.
An early analytical testing approach
New product development truly begins with raw material selection. Materials not subjected to early testing can contain impurities or contaminants that impact downstream biocompatibility issues, which can increase the risk of regulatory hurdles.
A supplier with in-house analytical capabilities already has established validated test methods for commonly used materials, and continually increases its knowledge of material trends. With the ability to produce custom reports quicker than third-party testing labs, Secant can get manufacturers the data they need to meet regulatory requirements and increase speed to market for the next medical device innovation.
Performance assessment areas:
- Absorption rate
- Chemical composition
- Physical structure
- Surface hardness
- Thermal morphological changes
Commonly evaluated materials:
- Coatings
- Controlled-release materials
- Partially absorbable materials
- Yarns
Partner with an ANAB-accredited testing laboratory
Secant Group’s analytical testing laboratory is ISO/IEC 17025:2017-accredited in the field of Testing. This accreditation, issued by ANSI National Accreditation Board (ANAB), enables Secant’s laboratory to perform analytical activities in the following categories:
- Material Identification (liquids, solids, polymers, resins)
- Molecular Weight Monitoring (polymers, resins)
- Assay for Purity (liquids, solids, polymers, resins)
- Molecular Weight Distribution (polymers, resins)
- Mass Compositional Analysis (solids, polymers, resins)
Mechanical
- Melting and Crystallization Temperatures, Enthalpy of Fusion and Crystallization, and Glass Transition Temperature (liquids, solids, polymers, resins)
Start your medical device project today.
Contact us to learn more or explore resources on medical device textiles.