InnovaCor™ does not manufacture, label, package, repackage, maintain, or control specifications for any products; all such activities are the sole responsibility of the product’s manufacturer. InnovaCor™ has implemented a quality program to effectively select and monitor suppliers and, as appropriate, to ensure proactive and timely communication to members.
InnovaCor's Quality Assurance Policy is as follows:
“InnovaCor™ provides members with a competitive advantage in the marketplace by providing members with access to cardiology, radiology, surgical and other health care and non-health care products with quality, value and efficiency.”
Because selection of products by members is totally voluntary, one of InnovaCor's™ core objectives is to select suppliers we believe will provide safe, efficacious, readily available and cost-effective products for use by its members. InnovaCor™ is committed to monitoring suppliers’ quality and regulatory performance, monitoring overall industry standards and, when appropriate, notifying members of any material quality or regulatory matters that might affect the membership.
To help ensure that all products meet the high expectations of its members, InnovaCor™ has implemented the following quality program:
Supplier Selection and Approval
InnovaCor™ selects and approves suppliers based on member direction and other predetermined criteria. Additionally, InnovaCor™ selects only those products that meet the highest quality and safety standards while delivering clear therapeutic and economic value. On members’ behalf, InnovaCor™ conducts a targeted review prior to the selection of any supplier.
Monitoring of Suppliers
InnovaCor™ quality assurance/regulatory affairs personnel monitor suppliers’ quality and regulatory performance to facilitate any necessary actions or communications with members.
Notification and Communication to Members
As a result of monitoring suppliers and the quality and regulatory environment associated with products, InnovaCor™ works to provide material information regarding the safety or efficacy of products to members in a timely manner. Events resulting in member notification may include product recalls, product shortages, consent decrees, customer complaint trends or other regulatory issues.
Product Complaints and Safety
When requested by members or contracted suppliers (manufacturers), InnovaCor™ will QA/R reasonably assist in the resolution of situations involving member complaints and safety concerns. In such cases, InnovaCor™ QA/RA personnel will endeavor to address any concerns to the members’ satisfaction.
Applicable Supporting Documentation and Procedures
- InnovaCor's™ Stanards of Business Conduct
- 21 CFR Part 211
- 21 CFR Part 820