Looking for reliable ISO 13485 consultants to streamline your QMS and accelerate your medical device ISO 13485 certification support? You’ve come to the right place. At Elexes, we specialize in providing tailored ISO 13485 consulting services for medical device and IVD manufacturers across the globe.
Whether you're launching a new product or upgrading your current system, our team ensures you meet every requirement under ISO 13485:2016 efficiently and effectively. We do the heavy lifting of documentation, risk management, and internal audits, so you can focus on product innovation and patient safety.
As ISO 13485 consultants, we don’t just offer templates, we deliver customized solutions. Our team begins with a deep dive into your existing quality system, identifies gaps, and develops an implementation strategy aligned with your device class, business model, and geography.
We support:
Need support with MDSAP, CE Marking, or FDA QSR alignment too? Our integrated approach ensures your QMS meets multiple standards with minimal redundancy.
Learn how our CE Marking Services align with ISO 13485 requirements.
⦿ Quality Management System (QMS) setup or enhancement
⦿ ISO 13485 Gap analysis and QMS audit preparation
⦿ ISO 13485 documentation and record development
⦿ Risk management (ISO 14971 integration)
⦿ Internal audit planning and execution
⦿ Supplier qualification and management system integration
⦿ Training for staff and management on ISO 13485 clauses
⦿ Support during third-party certification audits
⦿ Ongoing compliance maintenance and CAPA planning
Need help getting ISO 13485 while pursuing FDA 510(k) submissions? We can help.
Every company is unique. Our consultants build QMS systems that are lean, scalable, and suitable for your exact stage, whether you're a startup or a multinational manufacturer.
Our ISO 13485 consultants understand the nuances of regional requirements, be it Health Canada, EU MDR, TGA, or FDA. We align your QMS with the global market.
From SOPs to device master records, every document we prepare stands up to auditor’s scrutiny. You get clean, organized, and fully compliant documentation.
We help you implement systems that meet not only ISO 13485 but also MDSAP, 21 CFR Part 820, and other applicable frameworks, saving you time and cost.
Our job doesn't end with your ISO 13485 certificate. We offer ongoing support for surveillance audits, changes in the standard, and training for new hires.
See how ISO 13485 certification fits into your compliance roadmap and what to expect at each stage.
Your QMS Deserves Expertise. Let’s Build It Right.
Get certified faster and stay compliant longer with Elexes as your ISO 13485 consulting partner.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
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.
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.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
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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