Successful Quality Management Systems (QMS) assure that processes and procedures are implemented and followed so that customers are consistently delivered reliable and safe products. Certain medical devices that are considered high risk (Class II, III & LS/LS) are required to be manufactured according to QMS by the Food and Drug Administration (FDA) in the United States and the Medical Device Reporting (MDR) in the European Union (EU). Quality systems can be audited voluntarily through notified bodies according to the International Standards Organization (ISO) 13485 and be certified to be in compliance. Manufacturers wishing to sell high risk products in the EU must have met these certification standards to legally market and sell their products. Although there is not a notifying body for the FDA, on occasion the agency may show up to manufacturers to inspect their facilities and Quality Management Systems according to FDA 21 Code of Federal Regulations (CFR) 820 standards. All of the requirements can be found on the websites for either the FDA, or ISO 13485, both are very similar in nature but each has its own unique system of classifications.
A successful QMS always begins with a validated Approved Supplier List (ASL). Whether your company purchases finished products and repackages / relabels, or if you purchase raw materials to complete assembly, it is essential that Suppliers are thoroughly vetted, and once approved are constantly monitored to assure timely delivery and consistent adherence to specifications and tolerances that are mutually agreed upon. ACE Medical Company takes the additional step (and requirement) of having written Quality Agreements in place with all of our suppliers, specifically our ACE™ Kerrison’s, Wiggins™ Kerrison’s + Pituitaries, Ebner™ Surgical Scissors. ACE maintains Quality agreements for any all products that we manufacture and sell to our valued customers and using only approved suppliers assures customers that they are receiving consistent quality products.
ACE Medical Company™ manufacturers make Class I and II products and all are subject to the same regulatory requirements and good documenting practices are always followed. Important components are the Device History Record (DHR) archives of the labels for each device are kept according to document retention requirements all of which are consistent with both the FDA and MDR. Additionally, ACE maintains Device Master Records (DMR) unique to each unique instrument.
Production controls govern ACE Medical Company™ receiving, inspection and distribution of all products. The benefit of production controls to our organization is that it assures we match our manufacturers quality inspection criteria, guarantees traceability and could easily aid in an FDA or ACE initiated product recall. ACE Medical Company has implemented direct 2D data matrix marks to all of our products so that they can be easily scanned and identified to sale date, and serial number for each item. Our ACE Medical Company Liposuction Cannulas all bear this Unique Device Identifier (UDI) along with all of our other manufactured surgical instruments and equipment as outlined in recent the recent FDA directive “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.” As a final step all of ACE’s products are registered with the FDA’s Global Unique Device Identification Database (GUDID).