Medical device and in vitro diagnostic (IVD) medical device regulations in most markets require device companies to maintain a Quality Management System (QMS) to obtain device approvals and registrations. Failure to comply with QMS requirements can delay and interrupt approvals and registration, as well as impair your post-marketing relationship with regulators and product sales. In addition to fulfilling the legal requirements, IVDs and medical device manufacturers who want to stand out in the market should prove that they comply with the quality management system requirements.
Requalite can help you set up your QMS according to ISO 13485 and ISO 9001 in accordance with EU MDR and EU IVDR to safely bring your medical devices into the European market. In addition, our team of experienced auditors providing internal audits can determine and fix potential compliance issues before you are audited. We also provide QMS consultancy to the suppliers of manufacturers of IVDs and Medical devices in accordance with the ISO 9001:2015 standard. Our global team has experience in developing and optimizing quality systems compliant with ISO 13485:2016, ISO 9001:2015, MDR and IVDR.
As the regulatory environment evolves towards a process that emphasizes risk management at every stage, IVDs and medical device companies must incorporate risk management processes throughout their business. Integrating risk management into your quality management system is the most appropriate approach. If you are developing an ISO 13485 quality system in your company or already have one, we can design and document a system for managing risk to meet ISO 14971 requirements in addition to integrating ISO14971 into your existing QMS.
Whether you’re seeking assistance with internal audits, CAPAs, and risk management, or you want to delegate your entire quality management system, we can provide the most appropriate solution to assist you. We have offered support in many areas including the following