It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With help from Emergo’s medical device RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements worldwide.
Medical device and IVD classification determination and assessments
Classifying your medical device is an important first step in the device registration process. Your device class dictates its regulatory roadmap, including required documentation, clinical data and study requirements, safety testing requirements, and more.
We have experience classifying medical devices according to rules in the US, Europe, Japan, Brazil, Canada, and many other markets. Our team performs the toughest classification assessments for novel, borderline, and combination products. If needed, we will work with you to seek feedback from regulatory authorities on the appropriate classification for your product through pre-submission meetings.
Navigate complex medical device and IVD regulatory requirements
Medical device companies face an evolving regulatory landscape: market entry comes with more challenges than ever and maintaining compliance requires ongoing effort. Our consultants bring deep familiarity with opaque regulatory processes, such as:
- European Clinical Evaluation Report (CER) preparation
- EU MDR 2017/745 gap assessments and transition consulting
- Risk management planning and ISO 14971 implementation
- FDA UDI compliance consulting
Global market strategy for medical device companies
Because we work in so many different markets, we fully understand complex national regulations and where they overlap. We apply this knowledge for your benefit in a way that could not be achieved by working with separate consultancies or affiliates with limited local expertise. We will develop customized regulatory strategies that leverage your existing registrations. Whether you have one product or hundreds, we can help you expand your market reach to major and emerging markets worldwide.
Achieve QMS compliance in medical device markets worldwide
Medical device regulators in most markets require device companies to maintain a quality management system to obtain device approvals and registrations. Some markets recognize certification to international standards like ISO 13485; other markets require compliance with a local quality management regulation. Failure to comply with quality system requirements can prevent approvals and registration as well as jeopardize your standing with regulators post-market and disrupt product sales. Emergo’s quality management consultants bring decades of experience with medical device QMS development, implementation, and audits for all device risk levels. We can help you establish and maintain a quality management system that meets QMS requirements wherever your product is sold.
We develop, implement, and maintain integrated quality management systems that comply with QMS regulations in all major medical device markets, including:
We also assist with gap analyses, due diligence, and internal, supplier, and preassessment audits. Our consultants guide you through every step of the process, including writing quality management system procedures, conducting and monitoring the implementation, and training your employees. We also assist in on-going compliance and maintenance of your QMS following implementation and certification (where applicable).
Risk and quality management in one integrated system
As the regulatory landscape evolves toward a lifecycle approach that emphasizes risk management, medical device companies must incorporate risk management processes throughout their business. Integrating risk management into your quality management systems is the optimal approach. If you already have an ISO 13485 or FDA QSR quality system, we can design and document a system for managing and evaluating risk that meets the requirements for ISO 14971. Learn more about risk management consulting.