Team Elexes 
Elexes Team 
Elexes Regulatory & Quality Compliance Consultant
ISO 13485 Compliance
ISO 13458 is the globally recognized standard for medical device quality management that was published on February 25, 2016. The primary focus of ISO 13485 was on quality management systems which is now used as a framework by all medical device regulatory programs including MDSAP.
What is ISO 13485 Standard?
The ISO 13485 standard provides a framework that is essential to demonstrate compliance to regulatory requirements. This standard is meant for manufacturers, designers, as well as suppliers in medical device industry. This framework while keeping medical device industry players compliant to regulations also mitigates the risks to stakeholders.
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.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
The basic goal behind ISO 13485 standard is to:
- Ensure consistent quality
- Enhance product safety
- Sustain success of product or service
Key elements of ISO 13485 Standard -
- Explains requirements for risk management while encouraging process based decision making
- Effective alignment of global regulatory requirements
- Increased attention to supply chain processes
At Elexes Medical device consulting, we offer expertise in ensuring that your medical device manufacturing process and product itself stay compliant with the regulations.
We help with:
⦿ ISO 13485 certification readiness
⦿ ISO 13485 surveillance or recertification audit readiness
⦿ Pre-assessment audits
⦿ Gap analysis
⦿ Implementation of processes w.r.t. ISO 13485
⦿ Ensuring consistency between processes and practices
Our ISO 13485 experts will help you lay down the foundation of compliant procedures to be followed throughout the product development phase, saving a lot of money and time that otherwise will be spent on revisions.
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.
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.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
Local Regulatory Certification
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
Looking for assistance with your ISO 13485 certification?
If yes, our experts have years of experience to offer support for certification
Our New Product Approval Service Corner
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 -
Associated Regulatory Authorities.
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Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
“
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