Paradyne Medical’s Quality System complies with both FDA 21 CFR and ISO 13485 requirements. Our Quality System focuses on the following areas: Design Control, Risk Management, Document Control and Records Management and Supplier Management.
Paradyne Medical utilizes a six-phase approach to design and development and employs a systematic framework for capturing key aspects of your medical device product development to prove your product meets user needs and is safe and effective.
Risk Management is incorporated throughout our Design Control procedures and is an intrinsic part in all product lifecycle processes. Our ISO 14971 compliant Risk Management procedure was developed to ensure that all risks are addressed, documented and recorded throughout your medical device product development. We work closely with our customers to consider all risks associated with their products and make sure that they are appropriately addressed.
Paradyne Medical utilizes a computer based Quality Management System track approval and store all quality documents. Additionally, our customer will have access to all documents generated for our customer’s products during the product development phase and manufacturing phase.
Paradyne Medical utilizes a robust supplier management system. All our suppliers are carefully selected and undergo our supplier qualification process before being added to our Approved Suppliers List.