Headline
Sterilization Validation
Prove ISO 11135/11137 loads at worst case; half-cycle BI runs lock sterility upfront—no re-tests, no launch delays.
Headline
Cleaning & Disinfection
AAMI TIR12 studies verify soils, extraction, and residual limits, cutting post-market complaints.
Headline
Retrospective Validation
Leverage existing real-world data to satisfy FDA’s “least burdensome” path—shave months off prospective process validation.
Headline
Software / CSV
Draft, test, and document SDLC controls so connected devices clear regulatory review with confidence in your device’s software reliability.
Headline
IQ · OQ · PQ
Effectively verify installation and operating limits to produce a consistent product along with regular re-quals to keep your medical device process validation audit ready.
Headline
Risk & Protocols
Map process risks, write master validation plans for seamlessly execution that meet the FDA / EU acceptance criteria before a single test is run.
Case Study
Situation
A mid-sized medical device company needed full process validation for its Class II oncology device to meet aggressive FDA 510(k) and CE Mark submission deadlines. Lacking the necessary in-house expertise and resources, they sought external support to ensure their regulatory submissions were successful and on schedule.
Successes
- Launched 3-months ahead of schedule by aligning validation activities with ongoing design transfer milestones.
- Zero major findings during subsequent FDA inspection and Notified Body ISO 13485 audit.
- Successfully demonstrated process robustness and validation, enabling confidence in product quality and reproducibility at launch.
- Strengthened the client’s internal systems by providing templates and training for future validation activities.
Services by Veranex
- Embedded validation specialist to co-lead efforts with internal teams
- Development of a comprehensive risk-based Validation Master Plan (VMP)
- Authoring and execution of installation qualification (IQ), operational qualification (OQ), and process qualification (PQ) protocols for critical manufacturing equipment
- Coordination and oversight of environmental monitoring
- Documentation and support for regulatory submissions
Human Factors & Usability
Human Factors & Usability
Eliminate critical use errors and pass summative validation thus enabling safer devices, stronger adoption, and faster regulatory green-lights.
Quality Management Systems (QMS)
Quality Management Systems (QMS)
Implement ISO 13485 right the first time, pre-empting audit findings and reducing months of off market-clearance timelines.
Software Design & Development
Software Design & Development
Dominate SiMD: integrate firmware, UI, and risk-classified software that meets IEC 62304 and adds value to your device’s experience.
Design & Manufacturing Quality
Design & Manufacturing Quality
Achieve V&V-ready designs and bullet-proof DHFs that clear regulators without costly rework.
