Choose a complete package or build your own selection of procedures.

Procedure Review Service

Expert review of your procedures against ISO 13485, FDA QMSR and ISO 9001: findings report, redlined Word file, clause traceability table and one re-review. From $395, 5 business days.

Expert review of your procedures against ISO 13485, FDA QMSR and ISO 9001: findings report, redlined Word file, clause traceability table and one re-review. From $395, 5 business days.…

AI tools and eQMS software can draft a procedure in minutes. Whether it will stand up to an FDA inspection, a notified body or an ISO certification audit is a different question. A.P. Lyon reviews your procedures against ISO 13485, FDA QMSR and ISO 9001 before your auditor does.

What every review includes

Written findings report: gaps, potential nonconformities and improvement points, each tied to the requirement
Redlined Word document with tracked changes
Clause traceability table mapping each section to the ISO 13485 / FDA QMSR or ISO 9001 requirement it addresses
One re-review of your revised version within 60 days

Choose your review

1 procedure: $395, 5 business days
Up to 5 procedures: $1,495, 5 business days
Full QMS (manual + up to 25 procedures): $4,950, 15 business days, with a system coverage map

Who reviews your documents

Aaron Lyon, a former Senior Director of Regulatory Affairs. A.P. Lyon's working documents are installed in companies in more than 45 countries and have been used in FDA, notified-body and ISO 9001 certification audits.

Questions before ordering, or need an NDA first? Contact us.