Team Elexes 
Elexes Team 
Quality Management Services
We as regulatory and quality experts understand the importance of maintaining high quality management standards. With our Quality Management Services, medical device manufacturers get to enhance their operational efficiency while ensuring the highest quality standards are met.
At Elexes, we understand that every device is different and, therefore, provide customized solutions for each.
Looking for new product approval support?
Look no further!
Our Quality Management Services Include:
MDSAP Compliance
The MDSAP (Medical Device Single Audit Program) enables medical device companies to undergo a single audit that meets the regulatory requirements of multiple authorities, including the US FDA, Health Canada, Australian TGA, Brazil ANVISA, and Japan MHLW/PMDA. Our MDSAP experts help medical device companies be prepared for MDSAP audit by identifing compliance gaps, and providing actionable recommendations to ensure seamless global market access
ISO 13485 Implementation and Support
We also have ISO 13485 experts who help medical device companies implement a fully ISO 13485 compliant system that ensures that your manufacturing and marketing process is all meeting the standards. We conduct thorough gap analysis, audits and documentation to ensure end-to-end compliance.
ISO 9001 Certification
Another global standard that we offer support in is ISO 9001. We help organizations achieve ISO 9001 certification by streamlining processes, improving risk management, and ensuring continuous improvement. Our ISO experts have years of experience that help us commit to supporting you through each phase: from initial consultation to post-certification audits, helping you align your operations with internationally recognized best practices.
ISO 15189 Support for Medical Laboratories
We also assist medical laboratories with their ISO 15189 certification. Our experts will help you implement as well as maintain ISO 15189 compliant QMS. With our support, you can ensure the accuracy, efficacy, and reliability of testing processes. We conduct complete audits and offer support in maintaining proper documentation to ensure compliance.
Audits
Another part of QA process that we jump into is audits. Elexes is also renowned for helping medical device companies get thorough internal and external quality audits done regularly. Through these audits our experts help you uncover potential risks, evaluate compliance with regulatory standards, and support ongoing improvements.
Corrective and Preventive Actions (CAPA)
Corrective and Preventive Actions (CAPA) is essential means to rectify any quality issue that might arise in medical device company's quality management system. With our expertise, medical device manufacturers get support to develop and implement a robust CAPA system. Our experts help in determining the root cause and take necessary actions to mitigate those risks.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Our post approval compliance assurance process
- Strategic leadership and management of the QA/RA functional area
- Staff transitions or augmentation
- Special projects lacking internal bandwidth
- Early stage companies looking for strategic insights for QA/RA.
- Strategic leadership and management of the QA/RA functional area
- Staff transitions or augmentation
- Special projects lacking internal bandwidth
- Early stage companies looking for strategic insights for QA/RA.
Additional quality support services include
- Medical device single audit program (MDSAP) readiness audit
- Risk management (ISO 14971)
- Document control system implementation and remediation
- quality system implementation
- Quality system remediation
- ISO 13485:2016
- 21 CFR part 820
- Quality due diligence
Want to know more?
Our Services
Ready to Enhance Your Quality Management System?
Partner with Elexes for comprehensive Quality Management Services that will elevate your business standards, streamline operations, and ensure your products meet global regulatory requirements.
Compliance Assurance
Stay compliant with industry regulations and standards.
Cost-effective
Achieve regulatory success with Elexes, all within your budget.
Why choose
Elexes for medical device regulatory & compliance services?
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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Clients Testimonials
Amazing Feedback Say About 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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