Industry
Medical Devices
ISO 13485, MDR/IVDR and quality-system support for medical-device and combination-product manufacturers.
Overview
Medical-device and combination-product manufacturers navigate ISO 13485, EU MDR/IVDR and FDA QSR (21 CFR 820) simultaneously. Regulatory expectations have tightened sharply under MDR and IVDR.
PharmExpert supports device manufacturers with quality-system design, ISO 13485 readiness, risk management to ISO 14971, and audits — including for drug-device combination products that span device and pharmaceutical requirements.
Regulatory challenges
- Transition and compliance under EU MDR / IVDR
- ISO 13485 quality-system implementation and maintenance
- Risk management to ISO 14971
- Combination-product compliance across device and drug requirements
- Supplier control and post-market surveillance
How we help
- ISO 13485 readiness and implementation
- Quality-system design and remediation
- Supplier and quality-system audits
- Risk-management framework implementation
- Combination-product regulatory support
Relevant Services
Quality & compliance support for medical devices
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.