Text Box: Standard Wire Edition 10 – December 2005  

 

Text Box: IN THIS ISSUE FOCUS:   MEDICAL DEVICE INDUSTRY'S HURDLE OF FDA COMPLIANCE    Special Feature:  K. Dawn Plaskon, Director, Vintara Consulting Services discusses “The Key Steps to FDA Compliance”   Features Summary of ISO 13485 and Medical Device Manufacturers Conforming to ISO 13485 vis-à-vis ISO 9000 Interview with Regulatory Consultant on the Key Steps to Implementation How to quickly and cost effectively implement ISO 13485   Summary Today’s Standardwire discusses implementation of FDA’s established Quality System Regulation (QSR) requirement.  Our focus is on ISO 13485, the standard for Medical Device manufacturers.  We will answer the following questions: 1.      What is ISO 13485? 2.      Am I required to conform to the regulations? 3.      How do I make it happen? The Seven Key Steps to Implementing ISO 13485 4       If I conform to ISO 13485 do I meet the ISO 9000 requirements? 5.      Given the complexity of FDA’s QSR, how can I quickly implement and still be cost effective?  1.                  What is ISO 13485? ISO 13485 is the ISO 9000 for medical device manufacturers.  Incorporating the FDA’s best manufacturing practices, this standard recognizes that an effective quality management system is the crucial regulatory consideration for allowing medical device manufacturers to market their products worldwide.  The FDA established Quality System Regulation (QSR) requirements for all medical device manufacturers.  These requirements are separate from ISO 13485.  However, the FDA participated in writing ISO 13485 to ensure conformity of the two standards.  ISO 13485 specifies requirements for a quality management system enabling the enterprise to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.  The primary objective of ISO 13485 is to synchronize medical device regulatory requirements within quality management systems.  This means that if an organization meets ISO 13485 requirements, then it generally meets the FDA QSR requirements.    2.         Am I required to comply with the regulations? Manufacturers of Medical Devices distributed in the U.S. must comply with the QSR and five other basic regulatory requirements.  These basic requirements are: Quality System Regulation (QSR) Premarket Notification, 510(k) or a Premarket approval (PMA) depending on classification. Establishment registration on form FDA-2891 Medical Device listing on form FDA-2892 Labeling requirements Medical Device Reporting (MDR)   An enterprise has to conform with the FDA QSR requirements if, by definition, it is manufacturing a medical device that is used to: Cope, prevent, diagnose, treat, alleviate, or monitor human disease Care, diagnose, treat, alleviate, monitor, or compensate for human injuries Meet human anatomical needs Investigate, replace, modify, or support human anatomical structures Maintain, investigate, replace, modify, or support human physiological functions Support or sustain human life Control human conception Disinfect human medical devices Examine specimens taken from human bodies. Medical devices can include: Instruments, Appliances, Implants, Machines, Software, Materials, Calibrators, Apparatuses, In vitro reagents Manufactured products that achieve results by pharmacological, immunological, or metabolic means are not medical devices. SPECIAL FEATURE 3.         Seven Key Steps to Rapid and Cost Effective Implementation Dawn Plaskon, ASQ-CQA, CQMgr Director of Consulting Services Dawn Plaskon has over 20 years of experience in the areas of quality management, consulting and support services and documentation.  As Director of Quality Assurance and Documentation for Virtual Microsystems, Dawn was instrumental in developing a seamlessly automated installation process, as well as a comprehensive documentation set and beta test program for their networked coprocessor product.  As Quality Assurance Manager at DisCopyLabs, Dawn worked with the Director of Quality Assurance to develop a paperless, intranet-based system documenting both QMS requirements and pictorial work instructions, oversee and conduct an effective internal audit program and coordinate surveillance audits to maintain the company's ISO 9002 registration.  As the US Quality Manager for @Network, Dawn coordinated the development and deployment of an intranet-based QMS documentation system with the Worldwide Quality Manager.  Dawn attended the Accelerated Degree Program at Metropolitan College, Boston University and is a member of the American Society for Quality and the Project Management Institute. Ms. Plaskon's comments on implementation of a FDA compliant quality management system: I believe the daunting task of FDA compliance can be distilled in several key steps.  Any such implementation should utilize a Plan-Do-Check-Act (PDCA) methodology with a particular focus on regulatory compliance.  The seven key steps to a successful implementation are: Identify the requirements necessary to establish design and production controls for the organization’s specific and/or unique Class I, II, or III environment. Identify the Quality Management System (QMS) requirements that best suit the organization, based on its needs and size. Identify those key process areas of the QMS that must be addressed Document and set-up the processes of the QMS Establish controls for the overarching management of all documents and records affected by the QMS.  These will specifically include Design History Files and Device Master Records as well as the creation and approval of the other documents and records required to demonstrate adherence to the FDA’s QSR. Establish clear criteria that ensures senior management oversight of and involvement in the QMS as well as the competence of all personnel to fulfill their roles within the QMS. On-going management to ensure the effectiveness of an FDA-compliant Quality Management System.    4.         ISO 13484 versus ISO 9000 Certification By adhering to ISO 13485, an enterprise establishes a QMS that meets most of the FDA regulatory requirements.  The ISO 13485:2003 standard is based on the requirements of ISO 9001:2000 with additional specifications focused on meeting regulatory requirements of the medical device industry, worldwide.  The emphasis of ISO 13485 is on maintaining the effectiveness of QMS processes vis-à-vis QSR requirements rather than on customer satisfaction and/or business improvement; therefore, there is little need to be certified to ISO 9001:2000 as well.  Certification to ISO 9001:2000 may bring business benefits but is not necessary to meet the FDA QSR requirements.    5.         How can you quickly and cost effectively implement a FDA QSR? Vintara is the leading provider of fully automated, web-based enterprise quality and process management solutions and services within the international accredited standard environments of ISO 9001:2000 and ISO13485:2003.  Incorporating the FDA’s established Quality System Regulation (QSR) requirement, our application functionality and innovative technology crosses all quality and process standards to deliver the solutions that manage and administer quality, content, documents, and processes to meet international standards and requirements for medical device manufacturing.  Vintara enables the enterprise, regardless of its classification, to meet the regulations for quality, safety of use, and fit of purpose by electronically managing the design, purchase, labeling, storing, packaging, installation, and servicing of medical devices in accordance with QSR requirements.    Regulatory Compliance: We help you implement a best practices (GMP) system for the manufacturing and sale of Medical Devices.  Vintara software solutions support: Premarket Notification (510(k) or Premarket Approval (PMA) ISO 13485:2003 - Device Master Records - 21 CFR, Part 11 Corrective and Preventative Action (CAPA) - Internal Audits Identify your needs and size of System best for you Map and set-up your Processes and System, as required Install and administer a fully automated FDA compliant Quality Management System Benefits: Highly scalable to grow with your company as you grow Tools to implement, automate and streamline your processes Sets up an easy-to-use required Continual Improvement program Ready-to-use generic Configurable Templates of Documents Real-time access to your Performance Data from one central location Better Internal Communication by providing an easy-to-use interface Train your Administrator and Users on how to use the System  Contact Steve Anderson at sanderson@vintara.com or (510) 808- 2562 or Visit at ISO13.vintara.com The Connection between Standards, Compliance & Medical Technology