Manufacturing & Materials QA

Medical devices sold in the U.S. market must be safe and effective. The FDA requires that manufacturers follow Good Manufacturing Practices based on Quality System Regulation (QSR: 21 CFR Part 820) and its associated regulations. Domestic and foreign medical device manufacturers must put in place a quality system that addresses the design, manufacture, packaging, labeling, storage, installation, and servicing with the appropriate records for finished medical devices sold in the U.S. MCRA’s experts have the knowledge and expertise to help make your system compliant with U.S. requirements. Required quality system elements include:

• Document control
• Design control
• Risk management 
• Validation
• CAPA management
• Complaint handling
• Labeling, including Unique Device Identification (UDI)

Quality System Regulation (QSR)

• Does your quality system meet the requirements? MCRA can help you develop a plan to assess the gaps and then eliminate them.

Create a Quality System to meet QSR

• Do you have the resources to create a compliant quality system? MCRA can create and establish a quality system to meet your organization’s needs.

Create/review Device Master Records (DMR) and Device History Records (DHR)

• These records are required to meet QSR requirements that all processes required to manufacture the product are listed in the DMR and the DHR. MCRA can assist you with an independent review of these records.

Medical devices sold in international markets must be safe and effective. Most countries, require a manufacturer to have a quality system certified to the latest ISO 13485 standard as well as specific requirements for the country. The quality system must address the device's design, manufacture, packaging, labeling, storage, installation, and servicing, with the appropriate records for finished medical devices marketed in the country. MCRA’s experts have the knowledge and expertise to help make your system compliant with a country’s requirements. Required quality system elements include:

• Document control
• Design control
• Risk management
• Validation
• CAPA management
• Complaint handling

CE Mark Approval

Are you interested in marketing your medical device in the European Economic Association (EEA)? The EEA, which consists of the countries in the European Union plus other mutually recognized countries, requires your technical documentation to be reviewed and accepted by first a Notified Body and then a competent authority (CA). This device-specific requirement is in addition to having your quality system certified to the latest ISO 13485 standard. 

The CE Mark can be obtained once your technical file or design dossier (dependent on risk) is accepted by the competent authority. Do you have the resources to compile the technical documentation in an acceptable format? MCRA has been compiling and reviewing technical files and design dossiers for over a decade, including the latest requirements for Clinical Evaluation Reports (CERs). Let us assist you.

Summary Technical Documentations (STED)

Countries other than the United States and the EU may require the submission of a different file of technical documentation. This file of technical documentation is usually referred to as Summary Technical Documentation, or STED. As with CE Mark Approval documents, MCRA has created STED files for various clients interested in marketing their medical devices outside the United States or the EU.

Device Licenses

Your organization is seeking to develop a market for your medical device in a specific country. Do you know whether or not you would need an agent, a sponsor, a distributor or a license to develop this market? MCRA has assisted clients with navigating this requirement in many international markets.