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

With our medical device regulatory due diligence services, you can ensure that your medical device manufacturing process is compliant to all necessary regulatory requirements.

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.


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!

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