Services

At ISO13485clarity, we help guide you through the ISO13485:2016 requirements. We deep dive into every clause, as needed, and help you understand and implement solutions that work for your company. We are experienced in FDA Sec 820 regulations as well, since these are the foundation of ISO 134185. We also have experience with ISO 14791:2019 and ISO 27001.

At ISO13485clarity, we help determine the Classification of your medical device, and its place in the regulatory landscape. We identify devices as Class I, II, or III, and provide written justification for our conclusions. We give you a good roadmap for future responsibilities, based on the device’s Classification.

At ISO13485, we enjoy getting involved in the early stages of device development. Whether its planning test scenarios for your device, building a prototype, sourcing materials and components, documenting design activities, or risk assessment, our expertise can help you stay on the regulatory pathway.

At ISO13485, we help implement 13485 in your organization. This includes helping you design systems and controls that conform to all requirements. We cover everything from CAPAs to training to post-market surveillance. We support this with practical documentation. We write effective SOPs, forms, templates, records, and logs that support ongoing QMS maintenance.

Kevin McLellan is an ISO 13485:2016 certified Lead Auditor (BSI certificate). He is experienced in all types of audits: 13485 certification and surveillance audits, internal audits (usually for manufacturers), supplier audits, and quality audits. He can perform all audit activities. If you are seeking ISO certification from a Registrar, he can provide helpful insights.

We also provide services related to the federal HIPAA regulations. We help healthcare organizations and technology companies meet all HIPAA requirements. Our clients have included doctors’ offices and clinics, hospitals, SaaS providers, data analytics companies, EMR developers, nursing homes, cloud hosting vendors. Our sister company, HIPAAclarity.com, provides a full range of compliance services, including Risk Assessments, security policy development, BAA Agreements, Privacy Notices, and awareness training. See more at HIPAAclarity.com