Medical Device Consultants
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 System Products
Our world class ISO 13485:2016 quality system products help medical device manufacturers, specification developers and initial importers rapidly obtain ISO 13485:2016 and FDA QSR compliance. Our proven FDA compliant medical device sterile packaging validation protocol products help medical device manufacturers and specification developers gain needed confidence in their medical device packaging materials and packaging equipment.
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 truly enjoy helping medical device companies grow on multiple levels and ensuring our medical device products and services meet the ever changing global regulatory requirements.
Quality SystemsISO 13485 Quality Management Systems designed for manufacturers, specification developers and initial importers of medical devices.
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Validation ProtocolsOperational Qualification and Performance Qualification protocols developed for bar sealers, tray sealers and four sided sealing machines.
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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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