ISO 13485 & ISO 9001 Audits for Medical Devices

A certification, recertification or notified body audit should never come down to the day itself. BIO15PHARMA audits your ISO 13485 and ISO 9001 systems against the standard and against what auditors actually examine, so you know exactly where you stand before the date.

Who it is for

Quality and regulatory teams at medical device manufacturers and their suppliers, and any organisation preparing an ISO 9001 or ISO 13485 certification, recertification or notified body audit.

What we audit

• ISO 13485 quality management systems for medical devices, including FDA expectations
• ISO 9001 quality management systems
• Internal audits and supplier audits
• Notified body audit preparation
• Gap analysis against ISO 13485 or ISO 9001

Audit types

Internal audits, supplier audits, certification readiness audits, gap analysis.

Proof

More than 1,000 audits a year, in France and internationally. 100% delivered on schedule. Conducted to ISO and ICH standards by senior healthcare auditors. Every audit comes with a clear report and a corrective action plan you can act on.

Standards

ISO 13485, ISO 9001, FDA, EU MDR.

Contact us to prepare your ISO audit.