Quality Systems

  • United States

    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.
  • International

    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.

     

Manufacturing

The law requires “manufacturers” and those holding or owning a 510k to implement a quality system that meets QSR requirements found in 21 CFR Part 820. MCRA can help you create a quality system or modify your existing quality system to meet the requirements found in the QSR. Additionally, we have operations experts who can help you save money in your manufacturing process by optimizing your manufacturing efficiencies.

Internationally, manufacturers are required to obtain certification of their quality system to the current ISO 13485 standard and its associated standards. MCRA can help you create a quality system or modify your existing quality system to meet the requirements found in ISO 13485. Our services include:

  • Performing validations from planning through completion (process, software, design, cleaning, sterilization, and packaging), including direct interface with test laboratories 
  • Assisting with the implementation of lean manufacturing improvement systems
  • Process mapping and improvement

 

Employee Training Options

MCRA provides on-site quality assurance training to give your employees the opportunity to ask questions and interact with one another during the training process.

  • Document control
  • Design control
  • Risk management
  • Validation
  • CAPA
  • Complaint system
  • cGMP (current Good Manufacturing Practices)
  • Auditing
  • FDA inspection preparation

 

Technical Files & Risk Management

Medical device manufacturers must navigate obstacles to demonstrate conformity assessment, which is an important part of quality assurance requirements. Technical file formats vary, but there are key parts and requirements that must be met to avoid violating compliance standards. MCRA’s experts have the knowledge and experience to make sure you are fully compliant.

  • Create/review risk management plan
  • Create/review risk management files (DFMEA, PFMEA, FMEA)
  • Create/review essential requirements (ER) checklists, which are required for the CE Mark
  • Create/review technical file for class IIa and IIb medical devices in the EEA
  • Create/review design dossier for class III medical devices in the EEA

 

Design Controls

FDA requires proof of compliance with established design control procedures during the product design and development phase. Medical device manufacturers need to maintain records known as Design History Files (DHFs) documenting compliance with established design control procedures, and to have them ready for regulatory inspection once they obtain market authorization for their medical device. MCRA’s experts can show you how to properly create and maintain a DHF to ensure more efficient quality assurance down the line.

  • Design History File (DHF) reviews and remediation
  • Implementation of design control process
  • Facilitation of design review meetings

 

View Contact
Dan Goldstein

Dan Goldstein

Manager, Quality Assurance