We assess your quality management system against the ISO 9001 standard, which…
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Our assessments determine whether your quality management system complies with ISO 13485,…
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We evaluate your quality system in line with 21 CFR Part 820…
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We assess your electronic records and electronic signatures (ERES) to ensure compliance…
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Our compliance risk assessment identifies potential regulatory risks within your operations and…
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We evaluate the competence and training of your personnel, ensuring they possess…
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We assess your manufacturing facilities, ensuring they align with regulatory and quality…
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Our quality due diligence services focus on evaluating your quality management systems,…
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We conduct thorough reviews and assessments of your regulatory documentation and strategies…
Read MoreOur 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.
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.
Our consultants have extensive experience in the medical device industry, ensuring you receive accurate and up-to-date guidance.
We understand that each device is unique. Our assessments are tailored to your specific device and business goals.
We work efficiently to provide you with timely recommendations, helping you bring your device to market faster.
Our team stays current with the ever-evolving regulatory landscape, providing you with insights into future requirements.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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Team Elexes 
Elexes Team 
