Services
Project-based collaboration with comprehensive technical documentation & regulatory support for CODAN COMPONENTS, assemblies and complete non-sterile or sterile product solutions
Suitable for complex requirements, e.g. for authorised products / medical devices / devices for procedure packs including packaging, labelling and sterilisation or special customer projects.
Scope of delivery:
Complete technical documentation including:
- Product specification (stage 2)
- Comprehensive biocompatibility testing
- Physicochemical test reports
- Sterilisation and packaging validation
- Batch-specific certificates of conformity
- Close collaboration with the customer’s quality assurance and regulatory departments
- Comprehensive support for compliance with regulatory requirements
- Joint product registration (e.g. combination products)
- Tailor-made Quality Assurance Agreement (QAA)
- and more …
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CODAN COMPONENTS