Designing and developing your medical device is an important step but if you don’t appropriately understand and navigate the evolving regulatory affairs and clinical affairs your product will never see the market.
The experienced team at M.L. Reo Consulting has seen a lot of challenging situations in medical device regulatory affairs and clinical affairs (RA/CA). Whether it’s dealing with the US FDA or EU MDR guidelines, preclinical testing execution and management, clinical study support and management, new product submissions or post market support, our team can help give you the assurance that your product is compliant and remains in compliance.
We have experience working with companies of all sizes and requirements. No matter if your company is an experienced medical device manufacturer or a promising startup, M.L. Reo Consulting has the resources and capabilities to advise your regulatory affairs and clinical affairs.
Once your product is appropriately compliant from a regulatory perspective, we can aid you in the operations, and quality management systems for your device. Should you need design & engineering services for your next medical device, we can assist with that as well.
With over 50 years of combined experience, we’ve worked with businesses of all sizes, from start-ups to established manufacturers, to ensure that their medical devices are compliant with regulatory requirements.
We stand out from other medical device regulatory affairs consulting services because of this breadth of knowledge and hands-on experience.
Our regulatory affairs and clinical affairs services will appropriately navigate both pre-approval, approval, and post-approval issues to ensure your medical device gets to market.
Whatever your requirements, our medical device regulatory and clinical team can assist you in making them a reality.
With nearly 50 years of expertise in the medical device sector, we’ve worked on a diverse range of projects in a variety of medical fields, including:
No matter the medical sector, our medical device regulatory team can assist you in navigating your regulatory affairs and compliance milestones.
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