Clinical trial management support

It is vital that your medical device meets all regulatory requirements and we, at Elexes Medical Device consulting offer right resources to help you manage all the complex reviews needed for medical device clearance at the clinical trial stage.

Our team comprises of experienced medical device clinical research and regulatory experts who can help you at every stage of medical device manufacturer. Right from preparing early stage regulatory strategy to for preclinical interactions to commercial & post-marketing activities, we offer complete range of clinical trial management support.

Our Expertise

Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection.We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.

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Our expertise in clinical trial management support for medical devices

Our medical device clinical research and regulatory team of experts will help you create detailed usability files. Our services will include assisting you with -

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Our Services

Our Compliance Assessment Process

Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.

Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.

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We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.

Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.

Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.

So, if you are looking for a professional to assist you with clinical trial management, all you have to do is contact us.

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