Practice 05 · Expert-led consulting
Medical Devices
Toxicological evaluation and biological-evaluation scientific support.
Expert-led toxicological evaluation, biological evaluation planning, and material risk assessment supporting medical-device programs. Scientific consulting only — we do not provide certification, notified-body services, or regulatory decisions.
Scope of engagement
Aᴳ provides toxicological evaluations, biological-evaluation scientific support, and risk assessment for medical-device programs. Aᴳ does not provide FDA approval, EU MDR approval, certification, notified-body services, or regulatory-authority decisions.
Services
What Aᴳ delivers.
- ISO 10993 Toxicological Risk Assessment
- Biological Evaluation Planning
- Chemical Characterization Review
- Material Risk Assessment
- Extractables & Leachables
- Patient Exposure Assessment
- FDA Scientific Support
- MDR Scientific Support
- Device Material Safety Review
Industries served
- — Patient Contact Devices
- — Combination Products
- — Medical Packaging
- — Implantable Devices
- — Disposable Devices
Applicable regulations
- — ISO 10993 series
- — FDA guidance (scientific support)
- — EU MDR (scientific support)
- — ISO 14971
- — USP <661.1>/<661.2>
Related ToxIntel capability
ISO 10993 TRA & E&L workflow templates
ToxIntel is Aᴳ’s enterprise scientific safety intelligence platform — a distinct product that supports, but does not replace, the consulting practice.
Engage the practice
Talk to an independent toxicologist about your medical devices question.
Send a short brief — product, jurisdictions, timeline, and the scientific question that prompted the call. We respond within two business days.