Regulatory Gap Analysis

We specialize in providing thorough analysis to identify gaps in compliance with applicable regulations, guidances, and international standards governing medical software. Our team of expert consultants has extensive experience in assessing compliance for medical software products and can offer valuable insights to help you improve your organization's performance.

Considering the ongoing updates to regulatory requirements it is essential to stay on the top of these changes to maintain compliance with all the relevant regulations and standards. Failure to comply not only exposes your organization to legal and financial risks but also undermines your reputation and erodes customer trust. That's why we offer a comprehensive approach to compliance analysis that ensures you meet all the necessary requirements and stay ahead of the curve.

We work closely with your team to develop practical solutions that address any identified deficiencies and help you implement best practices that align with your business objectives.

Whether you need to comply with FDA regulations, ISO standards, or other relevant guidances, our team has the expertise and experience to help you achieve your compliance goals. We are committed to delivering exceptional service and support to our clients.

Are the services of True North applicable to companies of all sizes?

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We have had the privilege of working with a diverse range of medical software companies, from startups to established enterprises. Our services are designed to be adaptable and customizable, making them applicable to companies of all sizes. Whether you're a small startup or a large corporation, our team's expertise in navigating regulatory compliance can be tailored to your specific needs. We understand that the regulatory challenges faced by medical software companies can vary, and our experience allows us to provide effective solutions that fit the unique circumstances of each organization. Feel free to reach out to us to discuss how we can assist your company in achieving regulatory compliance, regardless of its size.

What are the steps involved in True North's comprehensive regulatory compliance process?

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Our process starts with identifying the regulations and international standards that apply to your product, based on its intended use and targeted markets. This initial step ensures that we have a clear understanding of the regulatory landscape that impacts your medical software. From there, we conduct a thorough assessment of your current processes and procedures to identify any gaps in compliance. With this information, we develop a customized regulatory strategy tailored to your business objectives. This strategy includes a detailed plan to address compliance gaps, implement necessary changes, and compile required documentation.Throughout this journey, our team of experts will guide you through the intricacies of EU MDR and FDA regulatory compliance, ensuring your organization is well-prepared for audits and submissions. We offer ongoing support to help you maintain compliance and navigate any new regulatory changes that may arise. Our goal is to ensure that your journey towards compliance is smooth and efficient, allowing you to focus on your core business activities and accelerate your time to market within the medical industry. Get in touch with us to learn more about how our streamlined approach can benefit your company's goals.

What is the expected timeframe for a typical engagement to achieve regulatory compliance with True North's assistance?

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The expected timeframe for achieving regulatory compliance through our services varies based on the specific needs and complexities of each client. Factors such as the current state of your processes, the extent of necessary changes, and the regulatory landscape itself can influence the timeline. We work closely with your team to assess your unique situation and develop a tailored plan. Our goal is to expedite the process while ensuring thorough compliance. Contact us for a personalized consultation to better understand how we can assist you and estimate a timeframe for your organization's regulatory compliance journey.

How does True North ensure that the regulatory strategy aligns with our business objectives?

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At True North, we understand that every organization has unique business objectives and requirements. Our approach to regulatory compliance is not one-size-fits-all; rather, we collaborate closely with your team to ensure that the regulatory strategy aligns seamlessly with your specific goals. By gaining an in-depth understanding of your company's aspirations, challenges, and operational nuances, we tailor our services to develop standard operating procedures (SOPs) that cater to your specific needs. This alignment not only ensures regulatory compliance but also maximizes your productivity and efficiency, making sure that the compliance process is harmonized with your overarching business objectives.

Which medical regulations and international standards does True North have experience with and can provide support to ensure our company achieves compliance with?

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We have extensive experience and a proven track record in supporting companies to achieve compliance with a range of medical regulations and international standards. Our expertise spans across both the US and EU markets. We're well-versed in the requirements of ISO 13485 for quality management systems, ISO 14971 for risk management, ISO 62366 for usability engineering, IEC 62304 for software life cycle processes, and IEC 82304-1 for health software. We're also knowledgeable about AAMI TIR 45 for guidance on the use of AGILE practices, ISO 15223-1 for symbols used in medical device labeling, and ISO 20417 for a common technical specification for medical device labels. Our thorough knowledge of these standards enables us to tailor our approach to your specific product and intended markets, expediting the process of achieving compliance while maintaining product safety and quality.

What distinguishes the tailor-made quality management system developed by True North from the ones available for purchase online?

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The distinction lies in the fact that the quality management systems available for online purchase are generally geared towards supporting hardware manufacturing, which prove cumbersome when applied to software development. In contrast, the tailor-made system developed by True North takes into account the intricacies of designing and developing standalone medical software, ensuring a more streamlined and effective approach to quality management that is precisely aligned with software-specific requirements and regulations.

What are the specific components of your end-to-end regulatory submission service?

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Our comprehensive regulatory submission service goes beyond compiling applications for FDA approval and navigating CE marking for EU compliance. We help define the intended use of your product and determine its classification, while also aiding in assembling 510(k) and technical documentation sections and product documentation. Additionally, our service includes managing communication with regulatory bodies, providing expert answers to any questions that may arise, and even taking an active role in audits when needed. Our collaborative approach ensures a tailored, accurate, and complete submission that meets regulatory standards, saving you time and resources in the compliance process.

What software development methodologies does True North use in its medical software SDLC?

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True North employs a hybrid approach, combining elements of Agile and Waterfall methodologies within our medical software SDLC. This blend allows us to effectively manage the complexities of medical software development. Agile principles provide flexibility for evolving requirements and iterative development, while Waterfall ensures thorough planning and documentation. This combined approach maximizes adaptability, quality, and timely delivery in the context of regulatory compliance and product excellence.