Quality Edge Management Consulting can help you determine the appropriate regulations that apply to your product and implement the proper processes for conformity.  We have the resources you need to develop and implement the Quality Management System that is right for you and establish the records that are crucial to successful product submissions.

Below are descriptions of some of the projects that might be on your agenda.  If, for example, you have a new product to market primarily in the U.S., preparation of a 510(k) premarket submission and the establishment of a Quality Management System based on the FDA's Quality System Regulation would be in order for your organization.  Penetration into the European and Asian markets would require conformance to a suitable Directive, the establishment of ISO 13485, and affixing of the CE Mark.

Premarketing submission must be made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device.  Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device, i.e., intended use, design, energy used or delivered, materials, etc.  It is the responsibility of the applicant to determine the classification of the device.  The FDA will make a decision regarding the SE and notify the manufacturer.  Implementation of the FDA's Quality Systems Regulation (QSR) is mandatory in most cases and data that is generated as a result of the design control procedures must be maintained by the manufacturer and be available for FDA inspection.

FDA’s Good Manufacturing Practices (GMP) / Quality System (QS) Regulation (or QSR) (21 CFR Part 820)

In the U.S. the Quality System (QS) regulation requires each manufacturer to establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured.  The regulation defines the essential elements that a QMS shall contain for design, production and distribution without stipulating specific ways to establish these elements.  Manufacturers must use good judgment and apply those sections of the QS regulation that are applicable to their specific products and operations. Good Guidance Practice (GGP) documents are available to provide information specific to a device. The manufacturer must maintain its QMS for inspection by the FDA.   

ISO 13485

This is an international standard based on ISO 9000:2000.  It specifies quality management system (QMS) requirements for regulatory purposes for medical device manufacturers and provides a framework to enable companies to meet their customer and regulatory requirements.  A major difference in the Standards is the focus on Continual Improvement and Customer Satisfaction in ISO 9001:2000 but not in ISO 13485. There are also additional documentation requirements particular to ISO 13485.  Initial third party independent review as well as periodic assessments are required to certify that the QMS remains compliant to the Standard. Many countries require certification to this Standard in order to do business within their boundaries.  The application of ISO 13485 is consistent with the FDA’s QSR, although it is not fully comprehensive.  

New Approach Directives

Medical Devices Directive (MDD), In-Vitro Diagnostics Directive (IVDD), Active Implantable Medical Devices Directive (AIMDD)

In the European Union, devices which are specified must conform to the appropriate directive in order to be sold or manufactured there. Classification of the device will determine the Conformity Assessment Process which is then defined in the directive.  The conformity process includes the requirement for a QMS (ISO 13485 is now commonly applied), review by an independent third party, retention of records, establishment of a representative presence in the EU and other particulars.  A Declaration of Conformity must be issued and registration made with the proper authorities.  Product manufacturers are entirely responsible for designing and manufacturing products under these directives.

CE Mark

The CE Marking is a mandatory (legally required) mark for any product that falls within the scope of a European Directive and is intended for sale in the European Market.  The actual purpose of the CE Mark is to be a visible indication to the EU member authorities that the manufacturer’s product is in compliance with the applicable directive.  The CE Mark must be affixed to products governed by the particular directive.