Bring your medical device to market faster
Regulatory
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.
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.
