Begin by defining your QMS Scope, Quality Policy, Quality Objectives and assigning key roles. Use our easy to populate templates while letting us ensure it aligns with ISO 13485 and any other regulatory intelligence you may need.

Tailor the mandatory ISO 13485 templates to your business and building records. Use our fully editable Procedures and Forms. Let us provide the ISO 13485 training for your team. We also advise on global regulatory expectations.

Introduce risk management, implement design & development controls and supplier controls. Use our complete Risk Management File, Supplier Evaluation Forms and Design Control Documentation.

Start using your forms daily and record evidence of compliance. We provide monthly support sessions while your team gets comfortable with the system and help with complaint trending, field safety corrective actions and regulatory reporting.

Perform internal audits across your QMS using the checklists and audit templates provided. We’ll provide internal audit support for your team or conduct a fully independent audit. Hold a management review meeting to evaluate performance and readiness.

Finalize your documentation and correct any remaining gaps before starting your certification process. Use our pre-certification checklist. Let us assess your QMS before your audit. We will also assistance with medical device files, market applications, and global registration pathways for other territories.