Elexes Team 
Team Elexes 
What is clinical evaluation report?
Clinical Evaluation Report (CER) for medical devices is a document that needs to be created and updated during a medical device’s lifespan. The CER must include inputs from risk management, verification testing, literature review and clinical investigations.
It is critical as per the regulatory requirements that CER file should to be updated and revised whenever there is any change in the device
We, at Elexes Medical Device Consulting have a team of experts who will help you prepare Clinical Evaluation Report (CER) for your medical device.
CER throughout the medical device life-cycle
The initial Clinical Evaluation Report (CER) is prepared during the development phase of the device which is carried out even after the launch of the product. Post launch, it is important that the report is updated regularly based on the post-market surveillance, newly discovered risks or indications and developments in the clinical fields.
Leveraging our Clinical Evaluation Report (CER) with 1000 different kinds of devices, we can help you:
Our CER Expertise
- Write your CER
- Update your existing CER
- Conduct a GAP analysis on your current CER
- Provide CEP/CER training
- Conduct clinical expert review
Our Expertise
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Our medical devices’ internal audit team can help you with -
- Supplier audits
- Current Good Manufacturing Practices (cGMP) compliance audit
- Current Good Laboratory Practices (cGLP) compliance audit
- Regulatory Gap analysis
- CFR Part 11 Gap analysis
- Pre-approval audits
- Risk assessment
- Development of inspection checklists
- Quality system audits (21 CFR 820 audit / ISO 13485 Audit)
- MDSAP audit
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Experience Team
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!
We, at Elexes have experts who will assist you in creating, maintaining, and updating your product’s Clinical Evaluation Report (CER).
So, if you are looking for support, all you got to do is
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.
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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