The US FDA regulates the design, manufacturing, packaging, labeling, storage and delivery of medical devices and IVDs. The laws requires "manufacturers" and those holding/owning the 510k (even if outsourcing the manufacturing) to implement a quality system that meets Quality System Regulation found in 21 CFR Part 820. The QSR is also commonly referred to as Good Manufacturing Practice (GMP).
Which medical device companies need to comply with the Quality System Regulation (QSR)?
In general, if your company manufactures a medical device or IVD, you will be required to implement a quality management system that is compliant with 21 CFR Part 820. The FDA considers you a "manufacturer" even if you completely outsource all of your manufacturing activities; therefore, most companies marketing a medical device or IVD must implement a QSR compliant system. Please note that Class 2 devices and most Class I devices are NOT exempt from cGMP requirements. Emergo can help you create a quality system that meets 21 CFR Part 820 or modify your existing ISO 13485 quality system to meet the requirements found in the QSR. We have implemented quality management systems for hundreds of medical device companies making a wide variety of medical devices and performing numerous manufacturing processes.
Meeting the requirements of Europe, Canada and Australia as well.
As mentioned above, Emergo's QSR consultants can modify your quality system to accommodate all requirements for Europe, Australia and Canada. With little additional effort, we can also ensure your compliance with Brazilian GMP and Japan Ordinance 169. Even if you have no immediate plans to sell in these markets, you will be well positioned for expansion in the future. If you already maintain ISO 13485 certification, we will ensure that our FDA QSR consulting team modifies your system in a way that seamlessly integrates all requirements into one system.