Safe Devices for Drug Products
Medical devices intended for the administration of medicinal products can impact the quality, safety, and efficacy profile of medicinal products. In the EU, devices co-packaged or cross-labelled as intended for drug delivery require gathering additional information to be approved for use. SAXOCON provides you with everything you need to test and document compatibility with drug products in compliance with regulatory requirements, including:
- The selection, screening, and characterisation of delivery device construction materials
- The selection of appropriate laboratories, review of protocols, and monitoring of extractable and leachable studies
- A toxicological risk assessment of results
Why choose us?
SAXOCON services for the development of drug-device products give you access to:
- Extensive, best-in-class experience with the development of drug-device products in accordance with the complex landscape of international standards and regulatory guidelines
- A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
- Safety evaluations based on proprietary information obtained from our worldwide network of materials suppliers
- Smart, cost-effective test strategies that bring your products to market in a timely manner
SAXOCON compiles all additional documentation necessary for developing a new Drug Application file in accordance with EMA requirements.
breathing gas pathways
Breathing gas pathway compliance.
Safe in-vitro diagnostics
(EU) 2017/746 (IVDR) Annex I compliance.
Safe stents and implants
Get your CE Mark certification.