Auditing
We ensure your systems are aligned, documented, and inspection ready.
Regulatory insight and operational know-how
As a MD and IVD manufacturer, you know maintaining a compliant, inspection-ready state across quality, regulatory, clinical, and post-market systems is essential yet challenging. Evolving regulatory expectations, global expansion, distributed supplier networks, and siloed documentation can all lead to audit gaps. Whether facing notified body audits, FDA inspections, supplier scrutiny, or internal compliance reviews, unprepared teams risk findings, delays, or even enforcement action. Effective auditing requires deep regulatory expertise, cross-functional understanding, and proactive risk identification.
Our expert auditing teams bring both regulatory insight and operational know-how. We design, conduct, or support audits across quality systems, clinical processes, post-market activities, and global registrations, tailored to your business model and compliance goals. Whether preparing for certification, responding to findings, or strengthening internal processes, we ensure your systems are aligned, documented, and inspection-ready.
Satisfied Clients
Discover how we can help:
Internal audits
We conduct comprehensive internal audits across your QMS to assess compliance with ISO 13485, MDR/IVDR, or FDA QSR requirements—identifying gaps before regulators do.
Mock audits and inspections
We simulate notified body or authority inspections (e.g. FDA, ISO, MDSAP) under real-world conditions to prepare teams and stress-test systems.
Supplier audits
We assess and qualify your critical and contract manufacturers, testing labs, and component suppliers—ensuring they meet regulatory and QMS standards.
Legal Entity Auditing
We audit individual legal entities within your group for organizational compliance, registration accuracy, and corporate regulatory obligations.
Post-Market Surveillance (PMS) and vigilance system audits
We review PMS plans, vigilance processes, complaint handling, and trend reporting for regulatory alignment and readiness.
(IVD) Laboratory compliance audits
We assess your diagnostic labs against ISO 15189, IVDR Annex I requirements, and national lab regulations to ensure clinical and analytical validity.
Clinical Audits
We audit clinical trial or PMCF activities, CRO oversight, investigator sites, and documentation to meet ISO 14155, GCP, and MDR expectations.
Device Registration Audits
We verify that your product registrations are current, traceable, and consistent across markets, minimizing the risk of expired or misaligned approvals.
Without regular audits, issues like undocumented changes, ineffective CAPAs, expired registrations, or supplier non-compliance can silently escalate into costly nonconformities. These inefficiencies can delay market access, damage reputation, and divert internal resources in remediation efforts.
We embed auditing as a proactive tool rather than a reactive burden. By assessing your systems with regulator-grade rigor and offering actionable insights, we reduce your audit risk, streamline compliance, and build operational resilience. Saving time, protecting certifications, and ensuring long-term regulatory success.
Couldn't find your question?
How often should internal audits be conducted?
Internal audits should be planned annually at minimum, with higher frequency for high-risk processes, new product introductions, or post-certification.
Can you help prepare for a notified body audit or FDA inspection?
Yes, we conduct mock audits replicating real inspection dynamics, helping you identify weaknesses, coach your team, and correct issues before regulators arrive.
Are supplier audits mandatory under MDR/IVDR?
Yes, for critical suppliers and subcontractors, regular audits are expected to demonstrate sufficient control and compliance with regulatory requirements.
What happens after the audit?
You receive a detailed audit report, risk-based findings, and a remediation roadmap. We can also support implementation of CAPAs and follow-up readiness checks.