Team Elexes 
Compliance Assurance
Stay compliant with industry regulations and standards.
Cost-effective
Achieve regulatory success with Elexes, all within your budget.
Regulatory & Quality Outsourcing Consultants for Medical Devices & IVDs
Streamline compliance, documentation, and project execution with outsourced expertise tailored to your goals.
Many businesses today prefer flexible, scalable solutions, and Elexes delivers just that. With our expert outsourcing consultants, you can access specialized regulatory, quality, and technical support without the overhead of hiring full-time staff. Whether you need full lifecycle project management or targeted compliance services, our team plugs seamlessly into your operations.
Reliable, Scalable, Efficient.
Why Elexes Is the Right Regulatory Outsourcing Consultant?
When outsourcing critical functions like regulatory submissions, quality documentation, or audits, experience matters. At Elexes, our consultants are not generalists, they are seasoned professionals in medical devices, IVDs, software as a medical device (SaMD), and combination products.
We’ve supported over 200 clients globally by acting as their regulatory outsourcing partner, managing everything from FDA submissions to ISO certifications, freeing up internal teams for innovation.
Services You Can Outsource to Regulatory & Quality Experts
Our outsourcing consulting services cover a broad spectrum of medical and diagnostic device functions:
⦿ Regulatory submissions (510(k), De Novo, PMA, CE marking, Health Canada licensing)
⦿ Technical file and design dossier preparation
⦿ QMS documentation and ISO 13485 implementation
⦿ Clinical evaluation and risk management
⦿ Post-market surveillance and vigilance support
No matter your need, we offer short-term, long-term, and project-based engagement models.
Outsourcing Services Built for Medical & IVD Excellence
We tailor our regulatory outsourcing services to your product, region, and business model.
Clinical and Performance Evaluation
We draft Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), and PMCF/PMPF plans aligned with global regulatory standards.
Regulatory Submission Management
Our consultants manage end-to-end FDA, EU MDR, IVDR, and Health Canada applications with full technical and clinical documentation support.
Quality Management System (QMS) Support
From ISO 13485 to MDSAP and CAPA development, our QMS experts can set up, optimize, and maintain your system.
Audit Readiness & Inspection Support
Be it an FDA, TGA, or Notified Body audit, we prepare your team and documents and offer live audit support when needed.
Project Management for Product Lifecycle
From concept to commercialization, our project managers ensure timelines are met and compliance is never compromised.
Outsourcing Consultants for Global Compliance & Growth
Startups and small manufacturers often struggle to afford full-time regulatory teams. Our consultants provide flexible support that scales with your growth.
If your team is downsizing or undergoing a transition, we act as your interim regulatory department, ensuring business continuity and compliance.
We develop, review, and maintain compliant technical files, QMS documentation, and post-market plans with real-time collaboration tools.
Planning to enter new markets like the EU, Australia, or Canada? Our medical device outsourcing consultants handle country-specific compliance, documentation, and submissions.
Combine regulatory, quality, and clinical tasks in one integrated outsourcing model. Our cross-trained experts ensure seamless communication and execution.
Avoid hiring missteps or consultant turnover, get access to vetted professionals who understand your industry, products, and goals.
Outsourcing Models that Deliver Value
Choose what suits you best—on-demand, retainer, or project-based.
Let’s Make Regulatory Simpler, Together.
Get the support you need, without the stress of hiring full-time.
FAQs
Frequently Asked Questions!
Outsourcing consultants provide specialized support in regulatory submissions, quality systems outsourcing, and FDA documentation outsourcing without being full-time employees.
Yes, it reduces overhead costs and offers access to experts on a flexible basis, ensuring compliance without long-term commitments.
Absolutely. Elexes offers modular outsourcing for specific tasks like audits, technical files, or QMS updates.
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.
We’ve More
Than 256+ Global
Clients
The Best RA & QA Consultants
Clients Testimonials
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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