Secure BioMed

Bring Your Medical Device to Market Faster and with Confidence

Helping You Every Step of the Way

Secure BioMed Evaluations operates as an extension of your team. Whether leading a project or supporting specific areas of your team, we seamlessly mesh with your organization.

Our clients appreciate our ability to form a cohesive team working towards commercialization of medical devices and biologics. We take pride in seeing your ideas materialize, whether bringing your concept to market or developing your concept for acquisition.

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SBME serves as not only top level consultants for their clients, but also resources of information.

Our Services

The Experience & Expertise to Get You Clearance and Approval


510(k), Presubmissions, Review of Marketing Material, Letter to File, Add to File, Regulatory strategy and Assessment

Quality Management

Training, Document and Record Control, Development of Quality Procedures, Response to 483s and Warning letters, Internal Audit support, Supplier, Prep

Technical Support

Validations, Testing, Toxicology Risk Assessment

Project Management

Drive Timelines, Budgets, Deliverables

Record Storage

Are you a virtual manufacturer? Do you need a physical location to store your quality system records and host audits? Do you need experts to facilitate your quality system audits for successful outcomes?

MQSM provides a novel solution for hosting quality systems for the virtual manufacturer.

The Secure BioMed Experience

Our dedicated team brings decades of expertise and experience to the table. When working with us, your goals are our goals. From the conceptual moment to the moment of market completion, you will experience confidence and excitement when working with the SBME Team.

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