Medical Device Quality Management Systems and Consulting
Medical Device Consulting
A.P. Lyon provides technical support during medical device design, development, and the regulatory approval process. Our staff is here to support you during each phase of product design, manufacture, and global distribution. A.P. Lyon also develops and installs FDA QSR and ISO 13485-compliant quality systems in facilities around the globe to help speed the regulatory approval process.
ISO 13485 Quality Management System Products
Our world-class medical device quality management systems help manufacturers and designers rapidly obtain ISO 13485, MDR 2017/745, and FDA QSR compliance. Our products are very robust and contain easy-to-follow content.
FDA US Agents
A.P. Lyon serves global medical device manufacturers as FDA U.S. Agents. Our US Agent services also provides support with FDA facility registration and medical device product data entry into the FDA Furls database.
We are very excited about our product offerings and the continued growth in our global consulting services. We enjoy helping medical device companies grow on multiple levels and ensuring our products and services meet the ever-changing regulatory requirements.
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Quality SystemsMedical Device Quality Management Systems designed for manufacturers and specification developers.
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Validation ProtocolsOperational Qualification and Performance Qualification protocols developed to support design and development activities.
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ProceduresISO 13485:2016 and FDA QSR compliant Standard Operating Procedures developed to fill gaps in existing quality systems.
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