Clinical Evaluation of Medical Devices
Discover a practical nine-step framework for building a structured clinical evaluation that connects clinical evidence, risk management, PMS, PMCF and technical documentation throughout the medical device lifecycle.
IVDR Validation for Lateral Flow Assays
Discover how to plan a risk-based validation strategy that connects intended purpose, performance evaluation, usability, manufacturing and post-market evidence throughout the LFA product lifecycle.
Usability Engineering for Medical Devices
Plan and execute a risk-based usability engineering process that connects intended users, critical tasks, foreseeable use errors, risk management, user-interface design and formative and summative evaluation to generate objective evidence for safe and effective device use.
Cleaning, Sterilization & Reprocessing Validation
Develop and execute a structured validation strategy that connects cleaning effectiveness, sterilization parameters, worst-case conditions, IQ/OQ/PQ and repeated reprocessing with objective evidence of device safety, performance and process reproducibility.
Transportation & Distribution Validation
Discover how a risk-based transportation validation strategy connects distribution conditions, worst-case packaging configurations, environmental conditioning, compression, vibration, drop testing and storage conditions with objective evidence of product and packaging integrity.
Sterilization & Sterile Barrier System Validation
Discover how to develop an integrated validation strategy that connects sterilization effectiveness, sterile barrier integrity, packaging performance, transportation and shelf-life evidence to demonstrate that sterility is achieved and maintained until the point of use.
Manual Cleaning Validation
Plan and execute a risk-based manual cleaning validation that connects device design, contamination challenges, worst-case cleaning conditions, residual testing, recovery methods and acceptance criteria to generate objective evidence of cleaning effectiveness.
Sterility Testing & Biological Indicator Verification
Develop and execute a structured microbiological verification strategy that connects biological indicators, worst-case challenge locations, fraction and half-cycle studies, recovery methods, controls and acceptance criteria with objective evidence of sterilization process effectiveness and reproducibility.