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A. P. Lyon

A. P. Lyon

A.P. Lyon is a medical device consulting firm providing products and services anywhere in the world assisting with MDR, ISO 13485 and FDA QSR compliance and medical device development.

ISO 13485 Quality System Products Help Medical Device Companies Comply with New Regulations

ISO 13485 Quality System Products Help Medical Device Companies Comply with New Regulations

The ever-changing medical device regulatory environment places design and manufacturing companies in the unenviable position of allocating valuable resources from active projects to focus on the strategic alignment of their organization and products with the new global regulatory requirements.The new…

Complaint Handling Procedures Simplify FDA and EU Compliance

A.P.LYON offers a solution for medical device companies engaged in the manufacture and global distribution of medical devices to ensure compliance with FDA, MDR EU 2017/745 and ISO 13485 requirements governing the process of complaint handling, reporting and any required…

Design Control Procedures Simplify ISO 13485 and FDA Compliance

A.P.LYON offers a solution for medical device companies engaged in the design and development of medical devices to help them comply with FDA and ISO 13485 requirements.The medical device Design Control Procedures Bundle includes multiple ISO 13485 and FDA QSR…

Risk Management Procedures Simplify ISO 13485, ISO 14971 and FDA Compliance

A.P.LYON offers a solution for medical device companies engaged in the design, development and manufacture of medical devices to help them comply with FDA and ISO 13485 requirements.The medical device Risk Management Procedures Bundle includes multiple ISO 13485 and FDA…

Products Streamline Compliance with New Medical Device Regulation (MDR) EU 2017/745, ISO 13485:2016 and FDA QSR

The new Medical Device Regulation places a greater emphasis on clinical evaluation and clinical investigations as part of the conformity assessment process. Current CE marked products will not be "grandfathered" and will need to meet the requirements of the new…

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