Team Elexes 
Regulatory due diligence
Medical Device Regulatory Due Diligence
Our years of experience in medical device regulatory and quality consulting has given us unmatchable understanding of best medical device regulations to conduct thorough and detailed due diligence for your product.
We, at Elexes medical device consulting conduct thorough and effective due diligence for your product from the early development stage, helping you stay compliant which minimizing the risk and improving the chances of regulatory clearance.
Different due diligence services we offer
Our team of regulatory experts can help you review your product’s regulatory strategy while planning the right approval pathway for your product based on the regulatory body you wish to get approval for eg. UK CA, EU MDR/IVDR, US PMA/IDE/510(k). We have medical device regulatory consultants who will carry independent assessment of your device’s design as well as development process against the regulatory requirements, QMS primarily ISO 13485 Section 7.3 & 21 CFR 820.30.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Standards compliance assessment
We, at Elexes medical device consulting have a team of regulatory consultants who can help you keep a check on your device’s compliance with several different applicable standards including :-
IEC 60601
Medical electrical equipment requirements
IEC 62304
Medical device software lifecycle processes
IEC 62366
Application of usability engineering to medical devices
ISO 10993
Biological evaluation of medical devices
ISO 11608
Needle-based systems for medical use
IEC 62304
Medical device software lifecycle processes
ISO 13485
Quality management systems (Requirements of regulatory processes)
ISO 14971
Application of risk management to medical devices
ISO 20072
Aerosol drug delivery device design verification
ISO 10555
Intravascular catheters
ISO 61010
Measurement, control, and laboratory equipment
Technical file and design history file review
Technical and DHF review is an integral part of medical device due diligence process. This is where our team of medical device regulatory consultants jump in. Our experts will help you carry out complete review of technical file and design history file of your medical device identifying any compliance gap in your documentation and guide you in filling it.
Manufacturing due diligence
Our understanding of medical device manufacturing make us count among the best medical device regulatory consultants who can help you carry out the detailed assessment of the status of robustness of the manufacturing strategy and systems of your product. We can help you identify the manufacturing risks or gaps while supporting you to create a perfectly compliant manufacturing process for your medical device. Our manufacturing due diligence services include -
Expert review of design for manaufacture (DfM) and design for assembly (DfA)
Review process’s
risk analysis
Supply chain evaluation including supplier selection
Assessing and reviewing the process equipment validation & qualification plans as well as reports
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.
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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Then 256+ Global
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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
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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.
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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.
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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.
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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
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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.
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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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