ISO 13485 Certification Consultant Needed

We are in the initial planning stages of building our ISO 13485 quality-management system and must cross the finish line with full certification no later than Q1 2027. I need a consultant who can guide us from this blank-sheet starting point all the way through the registrar’s audit, working closely with our team here in Guelph, Ontario (or at least within the Eastern Time Zone to keep collaboration smooth).

Scope of support
• Documentation and procedures – design, writing, and incremental refinement until they meet the standard’s requirements.
• Internal audits – create an audit program, train internal auditors, and run mock audits so we are inspection-ready.
• Employee training – develop role-specific training material and deliver ongoing sessions to embed the QMS culture.

What I’m expecting
– A realistic, milestone-based project plan that back-maps from a Q1 2027 certification date.
– Weekly video or on-site touchpoints to review progress, address findings, and adjust course quickly.
– Clear deliverables at each stage (draft QMS manual, approved SOPs, completed audit reports, training records, etc.) that will satisfy both internal management review and the external registrar.

Experience with medical-device start-ups or small manufacturers is a big plus, but solid, hands-on ISO 13485 implementation experience is essential. If you can keep us on schedule, own the heavy lifting for documentation, audits, and training, and are comfortable meeting weekly, I’d like to hear how you would lead us to certification.

We are currently ISO 9001 and 14001 certified and are pursuing ISO27001 and ISO 27701 certification.