A Notified Body audit or regulatory inspection doesn't wait for you to be ready. We align your management systems now, so your team is prepared before the auditor is at the door.
Audits and inspections are structured reviews of your quality, regulatory, clinical, and post-market systems against a defined standard. conducted internally, by a supplier, or by a regulator or Notified Body.
Regulatory expectations keep evolving, supply chains keep distributing across geographies, and documentation that made sense at one site rarely translates cleanly to another. None of that causes a finding on its own. It causes one when nobody's checked the connections between them before a Notified Body, FDA, or NMPA inspector does it for you.
Our auditors bring regulatory insight and operational experience across quality, clinical, and information-security systems. We design, conduct, and support audits tailored to your business model, whether you're preparing for certification, responding to a finding, or building internal capability your own team will eventually run.
Satisfied Clients
We audit clinical trial or PMCF activities, CRO oversight, investigator sites, and documentation to meet ISO 14155, GCP, and MDR expectations.
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.
We simulate notified body or authority inspections (e.g. FDA, ISO, MDSAP) under real-world conditions to prepare teams and stress-test systems.
We assess and qualify your critical and contract manufacturers, testing labs, and component suppliers—ensuring they meet regulatory and QMS standards.
We audit individual legal entities within your group for organizational compliance, registration accuracy, and corporate regulatory obligations.
We review PMS plans, vigilance processes, complaint handling, and trend reporting for regulatory alignment and readiness.
We assess your diagnostic labs against ISO 15189, IVDR Annex I requirements, and national lab regulations to ensure clinical and analytical validity.
We verify that your product registrations are current, traceable, and consistent across markets, minimizing the risk of expired or misaligned approvals.
We conduct comprehensive internal and mock audits to assess compliance of your Software as a Medical Device (SaMD) QMS with, among other standards and regulations, IEC 62304, ISO 27001/27002, cybersecurity, and data privacy and protection requirements, including the EU GDPR, Data Act, Cyber Resilience Act (CRA), and US HIPAA — identifying gaps before regulators do.
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.
How far in advance should we schedule an MDSAP, FDA, or NMPA mock audit?
Ideally 2–3 months before the real inspection. Enough time to close findings from the mock audit without rushing the fix.
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.
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