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Regulatory & Quality Compliance Consulting for LDTs & In Vitro Diagnostic Medical Devices
Elexes Regulatory & Quality Compliance Consulting is a trusted IVD medical device consultant globally. Our experts will help you seek approval for your In Vitro Diagnostic medical devices with the FDA, EMA, NMPA, MHRA, and PMDA.
We help IVD companies design a systematic regulatory framework for your device, facilitating global registrations. Along with designing the regulatory framework, we can help you maintain compliance with post-market requirements globally.
This is not all, with the growth in the LDT industry and the FDA’s forthcoming rule shift to regulate LDTs, it has become vital that there is proper support available for LDT manufacturers. After the staged approach outlined by the FDA in October 2023 proposed rule, the LDTs are expected to soon be regulated.
Determining Medical device, LDT, and IVD classification
A very important step in the regulatory route for LDT and IVD medical devices is to correctly classify the device. Classifying the In Vitro Diagnostic medical devices lays the foundation for determining the right regulatory roadmap.
At Elexes, we have IVD regulatory consultants who will help you classify the product accurately according to the rules in the US, Europe, Brazil, Japan, Canada, and other markets.
Our IVD Regulatory Services
Regulatory consulting services we offer for IVD companies
⦿ Gap Analysis
⦿ Global Regulatory Strategy Advice
⦿ EU-MDR and CE Registration
⦿ EU-IVDR Consulting Services
⦿ IVD Regulatory Services (Design and Development Process)
⦿ IVD Consultancy
⦿ Companion Diagnostics (CDx)
⦿ EUDAMED
⦿ Risk Management (ISO 14971)
⦿ USA FDA Market Access Consulting
⦿ Local Representation
⦿ PRRC – Person Responsible for Regulatory Compliance
⦿ Global Registration
⦿ Medical Device Registration in APAC and LATAM Countries
⦿ Notified Body-Like-Review for Technical Files
⦿ Interim Management
Our IVD Regulatory Services
⦿ Quality Strategy
⦿ QMS Implementation
⦿ MDSAP
⦿ CAPA Support
⦿ Internal Audit
⦿ Due Diligence Audit
⦿ Interim Management
⦿ QMS Maintenance
⦿ Training
⦿ Medical Device and IVD Training courses
Our IVD Regulatory Services
⦿ EU IVDR Compliance
⦿ ISO 13485:2016 QMS
⦿ Clinical Evaluation
⦿ FDA Submission
⦿ ISO 14155 GCP
⦿ Internal Auditor
⦿ Risk Management
⦿ CLIA Certification
LDT New Regulations | Know the Update!
The proposed FDA regulatory landscape for LDTs positions these diagnostic tests as medical devices. This means that LDTs will soon be subject to stringent regulatory frameworks similar to IVDs. This entire shift of policy is to enhance patient safety and bring in more reliable tests.
A Few Highlights of The Proposed Rule
As per the FDA’s proposed rule, LDTs will be added to the definition of “IVD products”. This step is to clarify that LDTs will fall under the medical device category.
The FDA proposes a tiered compliance strategy enforcing all the LDT manufacturers to meet all the required regulatory standards in stages, from one to four years post-final rule publication.
The proposed LDT ruile aims to include a wide range of LDTs with the assurance of closing any loopholes that allowed some tests to circumvent FDA regulations.
As per the proposed FDA rule, there will be no Grandfathering clause in it, meaning all the LDTs in the market will be required to meet with the FDA’s regulatory requirements.
As per the proposed rule, a few forensic or public health surveillance LDTs will be exempted from these new regulations.
Why Should You Hire Elexes as an LDT Regulatory Consultant?
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
Looking for professional audit support?
Look no further!
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Experience Team
Our Services
If you are looking for LDT/IVD/IVDR Consulting services, Elexes is one of the trusted RA/QA consultants. We have helped several LDT and IVD companies not only get medical device clearance from the associated regulatory body but also help them stay compliant with our post-market compliance consulting services.
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.
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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