Medical Device Validation Support
Medical devices must meet the highest safety, functionality, and efficiency standards. A well-planned validation program is critical—not just for compliance, but for ensuring a safe, effective product and a smooth approval process.
Medical Device Validation Programs
Validation encompasses a wide range of tests, and selecting the wrong program can lead to unnecessary costs and delays without delivering meaningful results.
With extensive experience in validation program design and execution, we help you develop a targeted, cost-efficient validation strategy that confirms your product’s key properties while optimizing time and resources.
We support you in both:
✔ Defining a tailored validation plan
✔ Organizing and executing validation activities
Medical device validations are conducted in-house or in collaboration with expert partners. Beyond validation, our expertise extends to quality assurance, covering 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)
- 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
Cleaning validation ensures that medical devices are free from contamination, 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
Medical packaging is essential for protecting the product and maintaining sterility after sterilization. Packaging validation ensures that processes remain stable during packaging, storage, and transport, guaranteeing the defined shelf life of both product and packaging.
Key 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
To be labeled as sterile, a medical device must achieve a Sterility Assurance Level (SAL) of 10⁻⁶. Various sterilization methods—including gamma radiation and ethylene oxide (EtO)—can be used depending on product requirements.
Our team provides:
- Consultation on selecting the right sterilization process
- Support in defining and executing sterilization validation
- Regulatory compliance guidance for global approval