Your Consulting Resource from Development to Launch
At Canyon Labs, we want to be more than just a test laboratory. We want to support your project throughout the full development cycle and into production by leveraging our team’s extensive technical background.
Our consultants provide a wide range of services to compliment our compliance testing. This includes regulatory & quality, packaging engineering, sterilization validations, biocompatibility risk assessments, and more.
By providing consulting services, Canyon Labs can truly be your one-stop-shop to support your submission and launch.
Packaging Consulting
Meeting regulatory standards is a complex and arduous process, so let us take on the burden for you. Our team of seasoned regulatory professionals has managed hundreds of projects requiring expert guidance in the following areas:
- Medical Device Submissions (510(k), PMA, De Novo)
- FDA Requirements
- EU MDR Requirements
- Q-Submissions (Pre-Submissions)
- Medical Device Registrations and Listings
- Labeling & Marking Guidance
- Quality Management Systems (QMS) Audits & Implementation
- Design History File (DHF) Gap Analysis
- Risk Assessments (PHA, FMEA, RMP, RMR)
- Sample Size Selections
- Compliance Testing Plans
- Requirements Traceability
- Verification Protocol / Report Review
Packaging Engineering
Medical device development takes a lot of resources and you may not have the bandwidth to work on your product’s packaging. Our team of packaging engineers can take the burden off your team by providing a turn-key service from design to validation. They are experts in the following areas:
- User-centric design
- Design for manufacturability & scalability
- Desing input refinement
- Supplier coordination
- Equipment procurement
- Validation Protocol / Report Authorship
- Sealing Process Validations (IQ, OQ, PQ)
- Transportation Validations (Environmental Conditioning & Distribution)
- Shelf Life Validations (Accelerated and Real Time Aging)
- Management and Execution of Packaging Testing
- Failure Root Cause Analysis
- Project Management
Sterilization Consulting
Developing an effective sterilization process is a critical part of every sterile medical device and pharmaceutical product. Each process must by validated to ensure your product remains sterile throughout its lifecycle and is safe for patients to use. Our team of experts and partners can help guide you in the following areas:
- Sterilization Modality Selection (EtO, E-Beam, Gamma, X-Ray, VHP, CD, etc.)
- Sterilization Cycle Development & Feasibility
- Sterilization Validation Protocol / Report Authorship
- Management and Execution of Microbiological Testing for Sterility
- Dose Mapping
- Dose Audits