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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...

IEC 62304

Meet SDLC Requirements If your medical device has software that regulates its functionality in a way that contributes to Basic Safety or Essential Performance, then you will need to comply with IEC 62304. The standard requires all aspects of the software development life cycle (SDLC) to be appropriately managed to ensure patient safety, including: Development and code reviews Risk management Configuration management Incident and bug resolution Validation Maintenance IEC 62304 Management Solutions All these SDLC activities generate a great deal of documentation that can be difficult to interpret and keep organized and readily available when they are needed. We use InfoStrength’s solutions (our regulatory software) and our expertise to organize your IEC 62304 SDLC management documentation for easier compliance, faster validation, and better process management – so you can meet your commercialization goals sooner. Meet IEC 62304 requirements with: Easy yet controlled access to your most current relevant SDLC and other GMP procedures Incident and bug management from identification to resolution validation Organized IEC 62304 and other relevant tables A secure collaborative environment between quality, regulatory and software development personnel with the appropriate document management and version controls to enable a smooth work process A portal with role-based security to exchange content efficiently and conveniently with your Notified Body Our goal is to help you achieve easier compliance, more efficient validation and improved process management. Be prepared – SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS...

IEC 60601-1

Organize your Risk Management Program For those who design or manufacture electromedical equipment, IEC 60601-1 3rd Edition A1 is one of the most important safety and performance standards to meet. The standard addresses critical safety issues, including the risk of electrical shock, fire hazards and mechanical hazards, such as entrapment risks. Devices that must meet current IEC 60601-1 requirements include those which: Diagnose, treat, or monitor the patient under medical supervision Make physical or electrical contact with the patient Transfer energy to or from the patient; and/or Detect such energy transfer to or from the patient. IEC 60601-1 Management Solutions Meeting the requirements of 60601-1 3rd Edition documentation requirements can be extensive and difficult to interpret. We use InfoStrength’s solutions (our regulatory software) and our expertise to provide structure to your product documentation for easier compliance, faster validation, and better process management– so you can meet your commercialization goals sooner. If you are currently in the very early design stages, now is the time to talk about the implications of IEC 60601. At this stage, we’ll work with you to provide IEC 60601-1 training for your engineering team. This training will guide the engineers in a way that allows them to: Think through  – well in advance of being ready to submit the product for testing – the impact of the standard on their design ideas Engage in more cost effective redesign early on Keep project milestones and plans on track by avoiding redesigns due to safety testing failures Our goal is to help you achieve easier compliance, more efficient validation and improved process management. Be prepared for your next FDA inspection...

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...

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....

safety testing management

Life Science Safety Testing Management When it comes to understanding safety testing and certification, we helped write the book… literally. Rita King, our CEO, participated in the development of safety critical software standards for UL and ANSI, giving us key insight into how certification is achieved. Right now, the immediate challenge is IEC 60601-1. The 3rd edition of IEC 60601-1 is a major shift from past iterations, changing the way medical devices go through safety testing. There is greater emphasis on risk management documentation and performance in addition to actual laboratory testing, and you now have choices in determining how safety and Essential Performance are maintained. Failure to adapt and conform to these changes will cause costly delays in getting your device to market. At MethodSense, we recognize that the IEC 60601-1 standard is intended to serve as an aid in the development of your Medical Device Risk Management Program. Our goal is to walk you through the documentation process, providing experienced guidance and interpretation, so you can achieve compliance and, if desired, certification. Safety Testing Management activities may include: Reviewing the standard you must comply with Conducting a gap analysis of your Risk Management Program against ISO 14971 Updating your Risk Management Documentation, Processes and SOPs Completing the IEC 60601-1 tables Submiting your documentation for certification Receiving safety certification ensures: Conformity to globally-approved standards Reduced risk of liability because of your documented safety standards Increased opportunities in the global market SCHEDULE AN APPOINTMENT WITH ONE OF OUR MEDICAL DEVICE SAFETY TESTING MANAGEMENT CONSULTANTS TODAY to ensure your device gets to market quickly and without unnecessary delay....