Regulatory
FDA Submissions and Pre-submissions, International Submissions, Review of Marketing Material, Letter to File, Add to File, Regulatory Strategy and Assessment
Quality Management
Development of Quality Procedures, Document and Record Control, Training, FDA 483 and Warning Letters Remediation, Internal Audit Support, Supplier Audits, Mock FDA and ISO Audits, General Quality System Support
Technical Support
Validations, Testing, Biological Risk Assessment, General Technical Support
Project Management
Drive Timelines, Manage Budgets, Track Deliverables, Due Diligence and Project Management for Product and Company Acquisitions
MQSM
MQSM is a service that will host your quality records at the MQSM facility, so auditors will have a single place to go to find all of your medical device paperwork.
Our Experience Is Among The Best In The Industry
Ready to have seasoned experts assist your device in getting to market?
