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ISO 13485 Certification Consultants for Medical Devices
ISO 13485 certification is the global benchmark for quality management in the medical device and IVD industry. At Elexes, we provide end-to-end support to help you achieve and maintain ISO 13485 certification with confidence. Whether you are a startup or an established manufacturer, our consultants streamline every step of your QMS implementation and certification process.
Why ISO 13485 Certification Is Essential
ISO 13485:2016 is not just a quality system, it's a strategic compliance asset. This standard helps demonstrate your organization’s ability to consistently meet regulatory requirements and customer expectations.
Global Market Entry
ISO 13485 is often a prerequisite for CE Marking, Health Canada licensing, and FDA QMSR alignment. It opens the door to major global markets.
Streamlined Product Development
A well-established QMS aligned with ISO 13485 supports efficient product design, risk management, and verification & validation processes.
Enhanced Risk Management
This certification strengthens your organization’s ability to identify, assess, and mitigate risks, reducing recalls and increasing patient safety.
Our ISO 13485 Consulting Services
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Elexes offers comprehensive ISO 13485 consulting services tailored to your product type, market goals, and current QMS maturity level.
Our support includes:
⦿ Gap analysis and ISO 13485 readiness assessment
⦿ QMS documentation development or remediation
⦿ SOPs aligned with ISO 13485:2016 and country-specific regulations
⦿ Internal audits and management review training
⦿ Support during notified body or registrar audits
⦿ Transition assistance for ISO 13485:2003 to 2016
⦿ ISO 13485 & MDSAP harmonization support
Learn more about our MDSAP certification services
QMS Services Tailored to Your Business Type
Medical Device Startups
⦿ QMS from scratch
⦿ Phase-wise implementation
⦿ Document control and CAPA setup
IVD and SaMD Companies
⦿ IEC 62304 & ISO 14971 integration
⦿ Validation of software QMS components
⦿ IVDR and MDR aligned documentation
Global Manufacturers
⦿ Localization of QMS for multi-country compliance
⦿ Audit preparation and representation
⦿ Supplier and subcontractor compliance
Explore our IVDR consulting and SaMD services
Your QMS Certification Partner From Start to Finish
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We don’t just guide you, we partner with you. From QMS design to regulatory inspections, Elexes offers turnkey solutions to achieve ISO 13485 certification faster and smoother.
How ISO 13485 Certification Works & Why Choose Elexes as Your ISO 13485 Consultant
FAQs
Frequently Asked Questions!
ISO 13485 certification is a globally recognized standard for QMS in the medical device industry. It ensures compliance with regulatory requirements and product consistency.
On average, ISO 13485 certification takes 4–6 months depending on your existing QMS maturity, document readiness, and team training.
Yes, ISO 13485 is typically required as part of the conformity assessment for CE marking under the EU MDR and IVDR.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
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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Amazing Feedback About Our Services
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
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
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.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
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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