Alquest services: Design controls for medical device companies

Alquest develops and implements Design Controls for manufacturers of medical devices including IVDs (in vitro diagnostics), biologics and combination products under ISO 9001/ISO 13485 and the FDA’s Quality System Regulation (QSR).

Our consultants have worked with all manner and size of manufacturer, spanning establishment of Design Controls through audits and “rescue” efforts. Alquest professionals scale the Design Control effort to the company, its products and culture.

How We Can Help

Design Control Procedures and Implementation
Design Control Audits
Design Development Plan
Design Control Project Management
DMR (Device Master Record)
Risk Management Program Development and Implementation per ISO 14971:2007
- Risk Management Plans and Reports
Risk Analysis
- Failure Modes & Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Preliminary Hazard Analysis (PHA)
- Health Hazard Evaluations (HHE)
Design History File Compliance
Biocompatibility/Sterilization Assessment
Device Standards Assessment
Process Validation (IQ/OQ/PQ)
Change Control