Remote Internal Audits
Under the FDA Quality Management System Regulation (QMSR), in force since February 2, 2026, internal audit reports are no longer shielded from FDA inspection. Your audit program now has a second reader. We plan and run independent internal audits, remotely or on site, and write reports that show a working system rather than a box-ticking exercise.
Risk-based audit program
An annual audit schedule that covers every ISO 13485 / QMSR process, weighted by risk, past findings and regulatory changes.
Remote audit execution
Document and record sampling via secure screen share, interviews by video, and live walkthroughs where useful. On-site audits in Türkiye and Europe when needed.
Inspection-ready reporting
Objective evidence, clear nonconformity statements graded by risk, and a summary your management review can act on.
CAPA recommendations and follow-up
Root-cause prompts for each finding and a follow-up check that actions were effective.
FAQ
How do remote audits work?
We agree an agenda and evidence list in advance, then audit through video interviews and secure screen sharing of your eQMS or records. Nothing has to be emailed in bulk. Processes that need physical observation are covered by a live video walkthrough or a short on-site visit.
Why use an external auditor?
ISO 13485 requires that auditors do not audit their own work. Small and mid-sized teams often cannot meet that internally. An external auditor also brings a fresh view of what an FDA investigator or notified body auditor will look for.
Can FDA really see our internal audit reports now?
Yes. The QMSR removed the former policy that kept internal audit, supplier audit and management review reports out of routine FDA inspection. Your reports should therefore be accurate, objective and backed by follow-up.
Other services
QMSR Gap Analysis
Check your ISO 13485 system against the FDA QMSR and related US requirements, with a prioritized action plan.
ISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
EU MDR & CE Marking
MDR transition, technical documentation, GSPR, ISO 14971 risk management and notified body preparation.
Supplier Audits in Türkiye & Europe
On-site supplier audits for US and EU manufacturers sourcing components or services from Türkiye and Europe.
Validation
Sterilization validation, test method validation, cleanroom and process validation reviews.
CAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.