At ISO13485 Clarity, we have expertise in all sections of the ISO13485:2016 standard. We help organizations — usually device manufacturers — meet all requirements and implement necessary systems, safeguards, and controls.

Through practical QMS development, we can help you implement the ISO requirements. In addition, we write policy documentation, and provide forms, templates, records, logs, and other tools necessary for QMS maintenance.

ISO13485 Clarity provides auditing services. Our principal consultant Kevin McLellan is a certified Lead Auditor. We help clients with internal audits, ISO13485 certification and surveillance audits, supplier audits, and quality audits. We review documentation and visit facilities as needed. A great deal of compliance work can be accomplished remotely.