Accelerate Regulatory Approval With Medical Device Regulatory Consulting
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.
Medical Device Regulatory Consulting Service for Market Success
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.
How MedQAIR’s EU MDR Consulting Services Can Benefit Your Business?
- Our US FDA regulatory consultants can assist businesses to remain abreast of the most recent changes as they are well-versed in the latest regulations, guidance, and policies in each country.
- We can assist you in creating a regulatory strategy that considers the objectives of the company, the intended use of the device, and the EU MDR regulatory landscape.
- Through our interactions with regulatory bodies, we can assist you in navigating the review process, answering any questions or concerns they may have, and, when possible assisting in accelerating the procedure.
- We can assist you with managing fluctuations in regulatory work without requiring you to hire more employees for temporary requirements.
- We can ensure that you stay in compliance with post-market obligations, such as product labelling updates and reporting adverse events.
Trust our EU MDR consulting specialists to navigate compliance effortlessly.
Frequently Asked Questions About Medical Device Regulatory Consulting
What is 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.
How can medical device regulatory consulting help my company?
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.
How does medical device regulatory consulting relate to quality management system (QMS) compliance?
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.
What are the key regulatory bodies overseeing medical devices in the US?
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.
How do I choose the right medical device regulatory consulting firm for my needs?
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.
Why choose MedQAIR to get comprehensive EU MDR consulting services?
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.
Relevant Insights
Explore in-depth insights into MDR, IVDR, and AI Act compliance.
