Understanding the unique requirements for Medical Devices

Medical Device & IVD Quality Assurance and Compliance

Medical device manufacturers are subject to a variety of Quality System regulations, intended to ensure the overall quality and safety of medical devices. Suppliers to the medical device industry, design firms and contract manufacturers, must also establish and maintain compliant quality systems in order to ensure their services meet these same quality requirements.

ICON works with manufacturers, and global industry suppliers to implement and maintain compliant quality systems. Our quality assurance professionals offer a broad range of expertise and have “hands on” experience with a wide variety of medical device products.

We will help you to prepare appropriate documents to bring your organization into compliance with the requirements of the FDA Quality System Regulation (FDA QSR) and ISO 13485:2003. In addition, we provide training, assistance in implementation, and final audit preparation for required inspections.

FDA Quality System Regulation (QSR)

In order to ensure that medical devices sold in the U.S. market are safe and effective, the FDA requires that manufacturers follow Good Manufacturing Practices (GMPs) as part of its Quality System Regulation (QSR: 21 CFR 820). Domestic and foreign manufacturers of medical devices must put in place a quality system that addresses the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices sold in the United States. ICON has designed and implemented quality systems for large and small medical device manufacturers; each customized to meet unique business requirements.

We will assist you with all aspects of your quality system requirements, including:

• Complaint Handling and Corrective and Preventive Action (CAPA) programs
• Design control, including risk management and design validation
• Document control systems
• Software quality assurance programs
• Process validation

ISO 13485 Compliance

ISO 13485: 2003 is an international standard that outlines the requirements for a comprehensive management system for the design and manufacture of medical devices.

This standard is recognized by the European Union, Japan, Australia and many other countries. Compliance with the standard is required by Canadian Medical Device Regulation. ISO 13485 is modeled on ISO 9000:2000, with additional requirements for documentation and provisions specific to medical devices. The standard is compatible with the requirements of the FDA QSR (Quality System Regulation). ISO 13485 also specifically requires risk management throughout the product life cycle, usually addressed through implementation of ISO 14971:2012.

Requirements for ISO 13485 include:

• The inspection and traceability for implantable devices
• Requirements for sterile medical devices
• Product cleanliness and contamination control
• Certification to ISO13485 is the part of the most common route to an EC Declaration of Conformity with European Directives for Medical Devices, 93/42/EEC, Active Implantable Devices 90/385/EEC and In Vitro Diagnostic Devices 98/79/EEC.

ICON helps companies to design a single system that meets both ISO 13485 and FDA QSR requirements. We prepare you for audit by a Notified Body, to certify that your organization has met the ISO 13485 standard. We will also train your staff to ensure a smooth and complete implementation.

ISO 14971 Compliance

ISO 14971:2012 is the current international standard for risk management for medical devices. It is recognized by the U.S., European Union, and Canada as a means to establish, document, and maintain a risk management program that complies with FDA, EU and Health Canada requirements. ISO 14971 outlines the risk management requirements to:

• Review a product’s intended use
• Identify and quantify any potential hazards during the design and development process
• Mitigate risks to a acceptable level and affirm the acceptability of risk prior to marketing a device.
• Establish processes to monitor products post-market and take action if risks are greater than expected or new risks arise.

ICON will assess your current level of compliance and design, implement, and establish a risk management program that will best comply with ISO 14971:2012, or allow you to manage, monitor and assess risk at all stages, from the design process, to manufacture and commercialization, through post-market surveillance.

Quality Assurance Audits

Once an FDA and/or ISO 13485:2003 quality system is in place, you must conduct routine audits to ensure that the system is compliant and effective. Without regular monitoring, there may be a reduction in product quality, a lack of process improvement, resulting in a possible loss of third-party certification, or FDA enforcement action. ICON offers a variety of audits to meet your specific needs, including:

• Gap Assessment Audits – Typically performed before quality system implementation (QSR, ISO 13485) to identify current level of compliance and areas for possible improvement.
• Pre-certification Audits – An internal audit, performed prior to the official registrar medical device certification audit to identify any outstanding areas of concern.
• Internal Audits – We offer two levels of internal audits – A full on-site quality system audit to review and examine existing procedures and provide recommendations for improvements, and a “desktop” audit focused on specific procedures of concern and typically conducted off site, through a review of relevant documents.
• Subcontractor / Supplier Audit – For those medical device companies that outsource some or all of the manufacturing process, we can perform on-site audits of vendors and suppliers to assure that products are manufactured in accordance with all applicable standards and regulations.
• Due Diligence Audits – A company’s ability to comply with the FDA and other regulatory requirements is a key indicator of its market potential. For those considering investment or partnership with a medical device firm, we provide an objective view of its current and possible future regulatory status.

Post-market Compliance

If quality assurance problems arise once a medical device has entered the market, either in the U.S. or internationally, we will work to respond quickly and re-establish compliance. Services include:

• EU Vigilance Reporting
• Appropriate enforcement action responses and/or corrective action plans in response to FDA 483s and warning letters
• Effective product recall strategies, including notification to applicable regulatory agencies and customers
• Post-market surveillance assistance to address complaint handling, failure investigation, problem reporting, and device tracking