Medical Device Validation Services
Our validation program design and execution services for cleaning, packaging and sterilization. We also offer quality assurance support and regulatory consultations.
Validation Strategy & Quality Assurance
With extensive experience in validation program design and execution, we support targeted, cost-efficient validation strategies to confirm your product’s key properties while optimizing time and resources.
We support:
- Validation plan definition
- Organizing and executing validation activities
- Quality Assurance management
Our medical device validations are conducted in-house or in collaboration with expert partners. Our quality assurance expertise covers everything from audits and CAPA management to handling defective products and customer complaints.
Comprehensive Validation Services
We cover all key validation areas, helping you demonstrate conformity, efficiency, and safety for medical device approval:
- Cleaning validation – Verifying product cleanliness and biocompatibility
- Packaging validation – Ensuring sterility and product protection
- Sterilization validation – Confirming effective microbial elimination
All packaging validation tests are available as in-house services, including Operational Qualification (OQ), Performance Qualification (PQ) and shelf-life determination.
Expert Validation and Quality Consulting
With our expertise, we support not just validation execution, but also the development of an efficient quality system.
We offer:
- Consulting on all quality-related matters
- Support for product approvals
- Validation program planning & test execution
- Organization of all validation activities
- In-house packaging testing
Cleaning Validation
Ensures that your devices are free from contaminants, including residues from manufacturing processes and microbiological contamination.
Common cleaning validation tests include:
- LAL Endotoxin Test – Detecting bacterial endotoxins
- Bacterial count determination – Assessing microbial contamination
- Cytotoxicity test – Evaluating biocompatibility
- Particle test – Measuring particulate contamination
Medical Device Packaging Validation
We provide packaging validation tests to guarantee the defined shelf life of your product, ensuring that sterility is not compromised during packaging, storage, and transport.
Validation tests include:
- OQ (Operational Qualification) – Establishing sealing parameters
- Shelf-life determination – Verifying packaging integrity over time
- PQ (Performance Qualification) – Proving process stability
- Transport validation – Ensuring packaging durability during shipping
Sterilization Validation
We use various sterilization methods—including gamma radiation and ethylene oxide (EtO), depending on the product requirements — to achieve a Sterility Assurance Level (SAL) of 10⁻⁶.
Our sterilization validation services include:
- Consultation on selecting the right sterilization process
- Support in defining and executing sterilization validation
- Regulatory compliance guidance for global approval