Medical Device Regulatory & Clinical Affairs Consulting Services

Helping you achieve compliance through approval & post-approval issues.

Our Medical Device Regulatory & Clinical Affairs Consulting Services

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.

FDA Submission Support

We will provide support for FDA meetings, submissions, and responses. We have supported 510(k) and PMA submissions as wells pre-market meetings in person and by conference call. In our network, we will source and back highly experienced regulatory consultants with US FDA division-specific experience as this is paramount for a timely and non-disruptive submission and approval.

CE Mark requirements

We comply with internal developed and vetted SOPs and MDR requirements to create viable Technical Files or Design Dossiers that will lead to a CE Mark.

Preclinical Testing

In Universities, hospitals, or preclinical study suppliers, we have performed setup, short and long term follow-up in multiple studies and models, acute and chronic, including resource acquisition, institutional contracts or purchase orders, protocol development, IACUC submissions, reports (GLP and non-GLP), and summary incorporations into physician brochures, Clinical Evaluation Reports (CER) and regulatory submissions.

Clinical trial support

We provide ISO14155 and GCP compliant support. In person, we have performed clinical trial development and execution activities, physician training, and surgery support.

MDR compliance

MDR compliance can be challenging. We have completed MDR compliant quality systems, and conducted MDR compliance preparatory audits.

Physician training

Whether a didactic, laboratory, or clinical setting, our team has trained cardiothoracic, vascular, gastrointestinal, ENT, oculoplastic, neurosurgical, orthopedic, and interventionalist physicians as well as their surgery or interventional teams.

Your Medical Device Regulatory Affairs Consulting Experts

Experienced Regulatory & Clinical Consultants

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.

Regulatory & Clinical Affairs Services

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.

Diverse Medical Field Experience

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:

Cardiovascular
Structural heart
Orthopedic
Peripheral vascular
Neurovascular and Neurological
Spinal Cord Stimulation
Ear, Nose, Throat (ENT)
Gynecologic

No matter the medical sector, our medical device regulatory team can assist you in navigating your regulatory affairs and compliance milestones.

Need medical device consultants you can rely on?

Product Realization, Delivered.