Timely 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
SAXOCON compiles all documentation in a Biological Evaluation Plan, which is the necessary first step to bringing your product to market.
Reusable medical devices
AAMI TIR12 compliant cleaning procedures.
CE MArk certificate
Certify your products for sale in the EU.
Stay ISO 13485 and 14971 compliant.
PMT analysis for ISO 10993-19 compliance.