Stay Compliant through Transition

Updated medical device technical files are a prerequisite for maintaining legal market access in the EU, the US, and other major regulatory regions. ISO 13485 and ISO 14971 mandate strict controls over design and development changes to ensure continued safety.

A typical change requiring updated documentation includes the introduction of new raw materials, processing chemicals, or transitioning to a new supplier. Furthermore, changes to manufacturing processes, including those managed by contract manufacturers, require a rigorous evaluation of their impact on a product’s biological safety and performance.

SAXOCON provides the specialized expertise necessary to evaluate how design and manufacturing changes affect your regulatory standing, with:

• Impactful Assessments: Evaluating the effects transitions have on existing biological evaluations per ISO 10993-1.
• Toxicological Risk Assessments: Expert analysis of new substances or altered concentration levels.

Why Choose SAXOCON?

Our services for medical device manufacturers give you the edge you need by providing access to:

• A Multidisciplinary Team: Expert toxicologists, material scientists, and supply chain professionals working in unison.
• Regulatory Excellence: Proven experience in state-of-the-art safety evaluations that meet international standards and withstand Notified Body scrutiny.
• Exclusive Data Insights: Safety evaluations informed by non-disclosed information obtained from our global network of material suppliers.
• Commercial Efficiency: Smart, cost-effective test strategies designed to minimize delays and accelerate your time-to-market.

Delivery

SAXOCON delivers a comprehensive toxicological statement supported by all documentation required for your Quality Management System (QMS). Our deliverables include necessary updates to your Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER), ensuring your technical files remain compliant and ready for audit.