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.

Company’s Keywords:

quality management system, risk management, medical input, risk benefit analysis, health hazard evaluations, post market surveillance activities, gap assessments, risk assessments, iso 149712012 compliance, class ii, iii medical device, calculating risk, patient safety assessments, probability of occurrence of harm estimation, severity of harm estimation, literature reviews, clinical evaluation reports, performance evaluation plan, performance evaluation reports, complaint handling, mdr, mdv filing, in vitro diagnostic devices, medical devices, pharmaceutical drug safety & vigilance, gdpr compliance, meddev compliance, health canada, systematic literature reviews, clinical evaluation plan, field corrective action, recalls, fda, food, drug administration, center of disease control, cdc, capa, corrective action preventive actions, supplier quality, doc control, digital assets management, medical supplies, ppe, procurement, purchasing, supply chain management, sourcing, logistics, 510k, pma, bsi, notified body