Process Validations

We support you in the compliant planning, execution, and documentation of process validations – including for:

• Seal seam and packaging processes according to ISO 11607
• Sterilization processes (e.g., EO)
• Thermal procedures, assembly, and labeling

We ensure reproducible results, reliable test plans, and economically appropriate testing scopes.

Method Validations & Test Evidence

We validate test methods for your medical devices or packaging units – in accordance with applicable standards (e.g., ISO 17025):

• Bioburden and sterility tests
• Leak tests, residual moisture, particle or endotoxin detection
• Test methods for transport, storage, and climatic stress
• Analytical methods for material or functional testing
• In cooperation with accredited laboratories, we coordinate planning, execution, and evaluation from a single source

Documentation & Regulatory Compliance

All validations are documented in a traceable manner in accordance with standards and regulatory requirements (ISO 13485, MDR, ISO 11135):

• Validation plans with risk analysis, acceptance criteria, and test methods
• Test protocols and result documentation
• Validation reports with assessment, conclusion, and release recommendation
• Re-validation strategies incl. trigger events and validity review

Consulting & Strategy Development

We develop customized validation strategies for your processes or product groups – risk-based, audit-ready, and economically feasible:

• Definition of valid parameters
• Selection of suitable test methods and laboratories
• Support with regulatory issues (e.g., MDR annexes)