Bring your medical device to market faster


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

Our Philosophy Your goals are our goals

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.

Our Philosophy
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Store Your Records With Us

  • 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.

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