Maven Med

Maven Med, Inc. was created with a specific vision in mind to improve the overall quality of patient care. Pre-COVID focus spanned between medical device consulting, Medical Education, and Medical Supply chain and logistics. Specifically, during COVID-19, we have been asked by many in our network for assistance in navigating the tangled web of PPE procurement. We strive to bring quality products at a low cost as our ultimate commitment to the safety of patients and healthcare providers. Services provided are as follows: - EN ISO 14971:2012 Risk Management Consultation - FDA, IVDR, MDSAP, and ISO 13485 gap assessments and remediation - Backroom assistance and guidance for audit management. - FDA 483 and Warning Letter Remediation - Clinical Evaluations for Adverse Event Reporting, Field Actions, Risk-Benefit Analysis. - Review of Post Market Surveillance process and optimization of trending and coding to patient safety issues - quickly identified and escalated for remediation in a timely, compliant manner. - Restoration of Quality System elements including but limited to Complaints Management, Adverse Event Reporting, Field Action Determination, Corrective and Preventive Action, Risk Management.