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Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic signatures, have you thoroughly assessed their function for 21 CFR Part 11 compliance? Do your document changes go through an approved change control process? Are document changes reviewed by the same person or personnel within the same function who previously reviewed and approved the document? Are your changed documents formally approved again? Do you consistently issue unique revision numbers to documents according to established procedures? Do you consistently document a description of changes to documents according to established procedures?  Are approved documents available at point-of-use for affected personnel? Are documents of external origin identified and is their distribution controlled? Do you effectively prevent the use of obsolete documents? Are your documents backed up to ensure efficient retrieval in the event of disaster? Have you validated your document control process or your electronic document management system as appropriate? If you answered—without hesitation—“Yes!” to all these questions, you are in great shape. Congratulations! If you answered “No” or “Maybe”, or if you had to pause and really think about the answer, then you might need some assistance.   The amount of controlled content created by a medical device company is extensive.  Lack of document control can create regulatory risks, risks to your Intellectual Property, and erodes the value of your operations and assets. Don’t wait for an audit or adverse event to assess and improve your Document Control System. If you need...

ISO 13485

Achieve ISO 13485 Certification ISO 13485 is a Quality Management System standard designed for medical device companies. Being ISO 13485 compliant shows a commitment to the safety and quality of your medical devices. Documented compliance to an ISO Standard, even in the absence of certification, speaks volumes about how you run your company and the kind of partner you will be.  For globalizing your medical device outside the United States, ISO 13485 certification is almost always required. Our medical device consultants will help prepare your business operations and documentation to establish your compliance with ISO standards and enable you to demonstrate your commitment to product safety, quality and reliability. If you are currently compliant with FDA regulation 21 CFR Part 820, MethodSense will ensure a smooth and efficient compliance path by fully leveraging your current Quality Management System. ISO 13485 Certification Solutions Our solutions allow you to confidently manage your quality, manufacturing, business processes and much more, with document control, record retention and audit trails. We support ISO 13485 certification with our proprietary pre-validated software solutions, InfoStrength Smart Enterprise Suite and InfoStrength Smart Solutions. This tool, combined with our medical device regulatory expertise, enables you to: Understand the requirements for ISO 13486 certification Establish a risk based approach to product development and realization Complete the validation of processes Ensure compliance with regulatory requirements Implement effective product traceability and recall systems Using InfoStrength Smart Enterprise Solutions, our regulatory document management tool, your materials will be organized in a way that makes it easy to demonstrate the safety and effectiveness of your device and risk management processes. Click here to learn more about...

21 CFR Part 820

FDA 21 CFR Part 820 Compliance Solutions Medical device manufacturers must establish quality systems and design controls to ensure their products meet applicable requirements and do not pose unacceptable risk to the consumer or public. FDA 21 CFR Part 820 is the Quality System Regulation that outlines current Good Manufacturing Practice (cGMP) requirements. Without a compliant Quality System, your device cannot be made available for commercial use. With the unique combination of our regulatory quality support and InfoStrength’s software solution, you can create a Quality System that demonstrates how you have built safety and effectiveness into your device. From navigating the regulatory requirements to interpreting the standards, we can help you achieve FDA 21 CFR Part 820 compliance. Meet FDA QSR Requirements MethodSense supports 21 CFR Part 820 compliance with our proprietary pre-validated software solutions, InfoStrength Smart Enterprise Suite and InfoStrength Smart Solutions. This tool, combined with our regulatory expertise, empowers you to manage controls and collaborative capabilities for device: Design Manufacture Packaging Labeling Storage Installation Servicing Technical files Our goal is to help you achieve easier compliance, more efficient validation and improved process management. Be prepared for your next FDA inspection – SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS...

good manufacturing processes

21 CFR Part 820 – Good Manufacturing Processes for Medical Devices If you manufacture a medical device, the FDA will require that your quality system meet the Quality Management System Regulations of 21 CFR Part 820, which outlines the current Good Manufacturing Processes for medical devices. The FDA enforces QSRs as part of the Safe Medical Devices Act to ensure that medical devices consistently meet specifications. To exhibit good manufacturing processes for medical devices, you must: Create a Quality Management System, which addresses the: risks presented by the device complexity of the device and its manufacturing processes size and complexity of your organization Establish controls necessary for your operation, which may include: Design controls Equipment and facility controls Production & process controls Records, documents & change controls Develop human factors related to the use of your product MethodSense is experienced in FDA GMP (good manufacturing processes) consulting and ISO quality system regulations for manufacturers in the US, Canada and Europe. For more information about how we can help with 21 CFR Part 820 compliance and Quality System (QS) consulting, contact...

iso compliance

ISO Compliance for Medical Device Companies ISO compliance for medical device companies demonstrates that International Organization for Standardization (ISO) guidelines are followed. Global commercialization of your medical device most often requires ISO 13485 Certification. Also, a deep understanding of ISO Standards, such as ISO 14971, is critical to establishing the safety of your product per IEC 60601-1 3rd Edition. Moreover, documented compliance to an ISO Standard, even in the absence of certification, speaks volumes about how you run your company and the kind of partner you will be. Our medical device consultants help prepare your business operations and documentation to establish your compliance with ISO standards and enable you do demonstrate your commitment to product safety, quality and reliability. Important standards for ISO compliance for medical device companies include: ISO 13485: design and manufacture of medical devices ISO 13485 is a quality management system standard designed for medical device companies. Being ISO 13485 compliant shows a commitment to the safety and quality of your medical devices. Our medical device experts will help you: Establish a risk based approach to product development and realization Complete the validation of processes Ensure compliance with regulatory requirements Implement effective product traceability and recall systems ISO 14971: medical device risk management ISO 14971 specifies a process for medical device manufacturers to identify the hazards, or risks, that are associated with their products and to create the necessary controls to monitor them. Our medical device consultants work with you to: Assess the essential performance of your medical device Identify potential hazards Estimate the severity and likelihood of the hazards Create controls to minimize the risks ISO 9001: quality...

QMS

Quality Management System Consulting for Medical Device Companies The FDA requires medical device companies to follow cGMP requirements and implement a Quality Management System (QMS) that demonstrates 21 CFR Part 820 compliance. This includes regulations for developing, manufacturing, packaging, labeling, storing, installing and servicing medical devices intended for human use. Complying with FDA Quality System (QS) Regulations ensures your product consistently meets regulatory requirements as a medical device manufacturer. MethodSense offers a wide range of Quality Management System (QMS) Consulting Services for Medical Device Companies: FDA Quality System Regulation (21 CFR Part 820) consulting for medical device manufacturers FDA GMP consultants for Quality System development and implementation Quality System internal compliance audits QA and RA due diligence audits of medical device products and companies FDA GMP audits for QSR 21 CFR Part 820 for medical device companies ISO 13485 consultants for global Quality Management System compliance Achieving an auditable standard of quality is a significant challenge for medical device manufacturers. We focus on enabling our clients to achieve the required levels of product quality in a way that delivers both operational excellence and an accelerated achievement of your goals with practical, implementable solutions. We also know firsthand that the most difficult aspect of compliance is maintaining it. Every year – every month – every week, there are actions that must be taken to demonstrate you’re in compliance with your Quality System. MethodSense can be part of your virtual quality team to ensure your auditability. Learn more about our On-Call Quality Support services to see if they are right for you! Contact us today for a complete review of your...