Materials Screening and Selection

The robust selection of construction materials for medical devices is key to establishing product safety and avoiding delays in time-to-market. SAXOCON provides you with all you need to assure a successful and cost-effective road map to document compliance with regulatory requirements, including:

  • A precise description of your product and its intended use
  • A 360° analysis of material candidates including chemical composition and supply chain
  • A selection of physical and chemical characterisations to screen for critical safety properties
  • A Biological Evaluation Plan to describe and justify your test strategy

Why choose us?

SAXOCON services for medical device manufacturers give you access to:

  • A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
  • Extensive experience in state-of-the-art safety evaluations according to international standards and regional regulatory guidelines
  • Safety evaluations based on proprietary information obtained from our world-wide network of material suppliers
  • Smart, cost-effective test strategies for bringing your products to market in a timely manner

Delivery

SAXOCON compiles all documentation in a Biological Evaluation Plan, which is the necessary first step to bringing your product to market.

Related Services

Reusable medical devices

AAMI TIR12 compliant cleaning procedures.

CE MArk certificate

Certify your products for sale in the EU.

Manage change

Stay ISO 13485 and 14971 compliant.

Surface Characterisation

PMT analysis for ISO 10993-19 compliance.