Navigate the regulatory landscape and quicken approval and market access for medical devices, IVDs, and AI-based solutions with our medical device regulatory consulting services.
Acquiring compliance and gaining access to the market can be made simple by selecting the right medical device regulatory consulting partner at the right moment. We offer regulatory consulting at every stage of the product development process. Our knowledge, resources, certifications, and experience in bringing compliant medical devices to the market make us your reliable partner for medical device regulatory consulting.
Medical device regulatory consulting involves providing guidance and support to manufacturers, importers, and distributors of medical devices to ensure compliance with relevant regulations and standards.
Medical device regulatory consulting services can provide expertise and support in understanding regulatory requirements, developing compliance strategies, preparing regulatory submissions, implementing QMS for medical devices, and resolving compliance issues.
Medical device regulatory consulting involves providing guidance and support to ensure compliance with regulatory requirements governing the manufacturing, distribution, and marketing of medical devices. Quality management system compliance is a key aspect of regulatory consulting, focusing on the establishment and maintenance of systems and processes to meet quality standards and regulatory expectations.
In the US, the primary regulatory body overseeing medical devices is the Food and Drug Administration (FDA). Additionally, the Center for Devices and Radiological Health (CDRH) within the FDA specifically focuses on medical devices and radiation-emitting products. These organizations are responsible for setting and enforcing regulations to ensure the safety, efficacy, and quality of medical devices in the U.S. market.
Consider factors such as the firm’s expertise and experience in medical device regulations, track record of success, range of services offered, client testimonials, and responsiveness to your specific needs and challenges.
To ensure that its products are placed in the market in accordance with the requirements of the EU MDR, a medical device company must implement a quality management system, conduct thorough clinical evaluations, ensure proper documentation, and obtain CE marking through conformity assessment procedures. Though all these things might be complex to wade through, the expertise of a seasoned EU MDR consulting company like MedQAIR can be of great help.
According to the Medical Device Regulation MDR (EU) 2017/745 and the In Vitro Diagnostic Medical Device Regulation IVDR (EU) 2017/746, all medical device manufacturers with products on the EU market must appoint a Person Responsible for Regulatory Compliance (PRRC). The PRRCs at MedQAIR bring extensive knowledge of diverse medical devices and hold qualifications in medical devices or IVDs.
Our quality and compliance consulting specialists assess the compliance of your product by thoroughly reviewing its documentation against the provisions of the EU MDR regulation. After identifying any gaps and areas for improvement, we develop the optimal solution, ensuring it is the most beneficial and convenient for you in terms of implementation.
We assist in determining the classification of your new or existing software based on the updated criteria introduced by the EU MDR.
Our consultants also offer guidance on post-market activities. We provide recommendations on best practices and solutions for activities such as monitoring and reporting, required by the EU MDR for software classified as a medical device already on the market.
Explore in-depth insights into MDR, IVDR, and AI Act compliance.
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