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By Industry
Medical Device
New Product Approval
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Audits
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Data Integrity & GMP Consulting
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ISO 13485
Clinical Evaluation Report (CER)
Outsourced Quality Support
Regulatory due diligence
Regulatory Agency Action Response
Import & Export Support
Clinical trial management support
Post Approval Support
SaMD & IVD
Cosmetic
Cosmetic Labeling Review & Claims
Cosmetic PIF compilation
Cosmetic Product Safety Report & Assessment
Packaging regulations
Cosmetic Post Market Assistance
Drugs & Biologics
Remediation strategy
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Medical Device Blogs
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Medical Device Blogs
November 13, 2023
Elexes Team
International Standards for design to market for Wearable medical devices!
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October 10, 2023
Elexes Team
MDSAP Audit | Complete Guide!
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September 21, 2023
Elexes Team
Importance of regulatory strategy
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September 11, 2023
Elexes Team
What is Telemedicine & its benefits & approval
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September 11, 2023
Elexes Team
HIPAA Law Violations: The Costly Consequences of Non-Compliance
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September 7, 2023
Elexes Team
Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups
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September 4, 2023
Elexes Team
Pros and cons of hiring a medical device consultant
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August 28, 2023
Elexes Team
ANDA or 505(b)(2)?: Choosing the Right Abbreviated Approval Pathway for Your Drug
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August 24, 2023
Elexes Team
13 Common Mistakes to Avoid in the 510(k) Submission
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August 21, 2023
Elexes Team
A Complete Guide to Hiring a Medical device consultant!
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August 14, 2023
Elexes Team
510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy!
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August 11, 2023
Elexes Team
Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
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August 7, 2023
Elexes Team
Difference between intended use and indications for use!
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August 4, 2023
Elexes Team
Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification)
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August 3, 2023
Elexes Team
The Top 10 Challenges Faced By Medical Device Manufacturers!
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August 3, 2023
Elexes Team
Abbreviated New Drug Application (ANDA): What it is, How it Works?
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August 2, 2023
Elexes Team
eCopy Medical Device Submission (How to create a successful eCopy?)
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June 8, 2023
Elexes Team
Top 5 Common Mistakes to Avoid in the 510(k) Submission
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June 8, 2023
Elexes Team
HIPAA Law Violations: The Costly Consequences of Non-Compliance
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June 8, 2023
Elexes Team
Staying Ahead of the Game:A Comprehensive Guide in Navigating the EU MDR
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February 20, 2023
Elexes Team
Here’s what companies look for while developing an IVD for a critical marker
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November 30, 2023
Team Elexes
Three New International Medical Device Software Security Standards Issued By FDA
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November 22, 2023
Elexes Team
Medical Device Design & Development Guide!
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November 13, 2023
Elexes Team
International Standards for design to market for Wearable medical devices!
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November 6, 2023
Elexes Team
CPSR for cosmetics: what is this report and how do you get it?
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October 27, 2023
Elexes Team
What is GMP & Why it is important?
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October 23, 2023
Elexes Team
What are GMP Audits, its purpose and how to be prepared for them?
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Latest Portfolio
Three New International Medical Device Software Security Standards Issued By FDA
Medical Device Design & Development Guide!
International Standards for design to market for Wearable medical devices!
CPSR for cosmetics: what is this report and how do you get it?
What is GMP & Why it is important?
What are GMP Audits, its purpose and how to be prepared for them?
What is Cosmetic PIF & Key Components to be included in it?
5 Common FDA Applications for Drugs & Biologics
MDSAP Audit | Complete Guide!
Women is the future of medtech innovations
Importance of regulatory strategy
FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!
Whether your product is cosmetic, a drug, or both? Learn the primary difference! (USA)
What is Telemedicine & its benefits & approval
HIPAA Law Violations: The Costly Consequences of Non-Compliance
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