Cybersecurity Compliance

Cybersecurity Compliance Support

Every medical device company or manufacturer understands the role of technology and its importance today in medical device development. The innovation in medical technology that elevates the quality of life for patients can also cause potential undermining for the organization using the device.

The consequence then can directly impact the device especially if god IoT cybersecurity, FDA cybersecurity standards, medical device security standards, and regulatory body’s cybersecurity protocols are not followed properly.

We, at Elexes Medical Device Consulting, offer services to medical device manufacturers to ensure there is a well-planned design the reflects full visibility of product development and the supply chain is in place, strengthening the medical device cybersecurity compliance.

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.

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) requests, product classification, Q-submission and international registration.

Pre-submission Support

Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

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What do Trustworthy Medical Device Cybersecurity Means?

A Trustworthy Medical Device Cybersecurity -

Contains hardware, software, and/or programmable logic that is based on regulatory body’s (FDA) guidance and standards
Provides a certain level or availability, reliability and defined operation
Suitable for performing its intended functions
Follow the generally accepted medical device security procedures

8563 +

Saticfied Custimer

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Experience Team

Elexes Medical Device Cybersecurity Consulting

At Elexes, we offer a complete range of consulting services that ensure that your medical device’s cybersecurity is compliant to all the regulatory regulations leaving no compliance gaps.

Over the years, we have established ourselves as one of the trusted cybersecurity consulting firms for medical device manufacturers. Our industry knowledge and customizable compliance solutions make us the best place for medical device & SaMD companies to come to for cybersecurity compliance assurance.

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

Initial Consultation

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.

Regulatory Expertise

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.

Document Review

We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Gap Analysis

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.

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.

Ongoing Support

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 -

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) request, product classification, Q-submission and international registration.

Pre-submission Support

Associated Regulatory Authorities.

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Then 256+ Global Clients

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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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