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ISO 14971

Achieve ISO 14971 Certification 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. Understanding this regulation is also critical to establishing the safety of your product per IEC 60601-1 3rd Edition Amendment 1 requirements. At MethodSense, 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. ISO 14971 Certification Solutions ISO 14971 establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. These activities are also required by higher level regulation and other quality standards, such as ISO 13485. 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 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 our regulatory document management software. Our goal is to help you achieve easier compliance, more efficient validation and improved process management. SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS TODAY to ensure your device meets global commercialization...

FDA clearance

  MethodSense FDA Clearance Consultants Help You Obtain FDA Clearance for Medical Devices The path to medical device commercialization and FDA clearance is determined by many factors. Usually this means filing 510(k) pre-market notification with the FDA. However, in some instances, it might mean taking a PMA or de novo path to market. Our FDA consultants work with you to determine the best route to market for your product and support you throughout the entire process – which can get quite complicated depending on the characteristics and intended use of your device. While there are different activities that must be completed, many happen concurrently. Although this is not an exhaustive list, some of the activities you may perform are outlined below: Product Analysis and Regulatory Roadmap Identify if your product is a medical device Determine or confirm your product code and classification (Class I, II or III) Class I or Class II devices may be FDA exempt, follow a 510(k) path, or follow a de novo pathway Class III devices follow a PMA route In some cases, a predicate may not be available. When this occurs, we evaluate whether the de novo pathway is an available route for your product. Planning Assess existing information you have created that will support your submission Identify and prepare additional materials necessary for FDA review Identify studies and testing that might be necessary Plan FDA communications Pre-Submission Activities Plan Pre-Submission meetings with the FDA, which might include conversations about: Investigational Device Exemption (IDE) Clinical Studies Clinical Trials Human Factors Testing Safety Testing Software Validation System Verification & Validation Prepare protocols and manage projects...

regulatory affairs

Regulatory Affairs Consulting Regulatory requirements impact your products – and your business – throughout their entire lifecycle. Especially when you consider that regulations are constantly changing. A single regulatory misstep or misunderstanding may stand between your financial success and misfortune. Our regulatory professionals work with you to develop and execute a roadmap to commercialization by ensuring you meet the evidentiary requirements that demonstrate the safety and efficacy of your medical device. Our experience covers regulatory requirements of the US, Canada and Europe. Regulatory Affairs Consulting Services We Offer Include: Regulatory Roadmaps Strategy for US commercialization with FDA 510(k), PMA and de novo Strategy for EU and Canadian commercialization with CE Marking Regulatory Gap Analyses Regulatory Compliance Initiatives GxPs, 21 CFR Part 11 and Annex 11 European Directives and CE Marking FDA Submissions to Obtain FDA Clearance Medical Device Technology and Software Validation Human Factors Validation HIPAA Representation before Regulatory Bodies Submission Support: Document Preparation Guidance for Pre-Submission Meetings Risk Assessment and Remediation Strategies Submission Changes Quality and Product Certifications IEC 60601-1 3rd Edition Amendment 1 Safety Testing Documentation Preparation ISO 14971: 2012 Compliance and Documentation Preparation IEC 62304 Software Development Lifecycle Compliance ISO 13485 Compliance and Documentation Preparation Test Laboratory Document Submission Auditing Services Internal Audits and Compliance Remediation External Audits and Vendor Management Compliance SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS TODAY to ensure your device gets to market quickly and without unnecessary delay....

regulations

Satisfy Quality & Regulatory Requirements Determining this safety is often rigorous, time consuming and document heavy. MethodSense’s combination of software and consulting experience pairs to position your life science product and business operations to meet US FDA and EU regulatory affairs safety standards requirements for commercial success. 21 CFR Part 11 Manage quality, manufacturing, and business processes FDA 21 CFR Part 820 Create a Quality System that demonstrates the safety and effectiveness of your device IEC 60601-1 3rd Edition Achieve easier compliance, validation, and process management IEC 62304 Keep your SDLC activities organized and readily available ISO 13485 Commit to the safety and quality of your medical device ISO 14971 Identify and manage your medical device...