Auditing, supplier oversight and risk management for medical devices, SaMD, AI, digital health and IVD manufacturers

An audit should do more than confirm that procedures exist. The real value comes from understanding how systems operate in practice and where weaknesses may be creating unnecessary risk. Our team of MedTech regulatory specialists conducts internal audits, supplier audits and independent external audits against applicable regulatory requirements and industry standards. We help organisations identify compliance gaps, prioritise improvements and maintain ongoing market readiness across quality, regulatory and operational activities.

Unexpected regulatory challenges can place significant pressure on development programmes, approvals and commercial activities. Our MedTech regulatory consultancy team provides rapid-response support for audit findings, inspection observations, quality system deficiencies and compliance remediation projects, helping our customers regain control quickly and move forward decisively.

Preparation is critical when facing notified body assessments, certification audits or FDA inspections. We conduct realistic mock audits based on current regulatory expectations to assess organisational readiness, identify vulnerabilities and address compliance issues before official inspections occur. Our practical, risk-based approach provides confidence and helps reduce the likelihood of unfavourable regulatory observations and findings.

Successful audits often depend on the work completed long before inspectors arrive. We work in partnership with MedTech organisations to prepare documentation, challenge assumptions and assess readiness well in advance of formal assessments. Following an audit, we help interpret findings, prioritise actions and strengthen systems where weaknesses have been identified.

Supplier oversight often becomes a focus area during inspections because manufacturers remain responsible for the quality of outsourced activities. We help organisations establish appropriate controls and demonstrate that suppliers are being managed effectively.

Risk management is often viewed as a regulatory requirement, when its real purpose is to support better decision-making throughout development and commercialisation. We help organisations integrate risk management and, where applicable, software lifecycle processes into everyday activities rather than treating them as standalone compliance exercises, supporting medical devices, IVDs, SaMD and digital health technologies throughout the product lifecycle.