Sector
Medical Devices
We support medical device manufacturers in medical software validation (IEC 62304), implementation of quality management systems compliant with ISO 13485, and compliance with the European Medical Device Regulation (MDR 2017/745).
Applicable regulations
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System Validation
Complete validation of computerized systems: ERP, LIMS, MES, mobile applications, medical devices and AI systems under GxP regulations and 21 CFR Part 11.
Auditing
Internal audits, technology vendor and third-party audits to identify compliance gaps and prepare your organization for regulatory inspections.
Regulatory Consulting
Expert advice on the interpretation and application of GxP regulations: FDA, EMA, ICH, ISO 13485, MDR and other regulations applicable to your sector.